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Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

Patients greater than or equal to 3 years of age and < 22 years of age with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma using reduced craniospinal radiotherapy.

Christopher Moertel, MD
moert001@umn.edu
All
3 Years to 21 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02724579
STUDY00002501
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Inclusion Criteria:

• Patients must be newly diagnosed and have:
• Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1:
• Classical histologic type (non LC/A) WNT medulloblastoma
• Positive nuclear beta-catenin by immunohistochemistry (IHC)
• Positive for CTNNB1 mutation
• Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)
• Patient must have negative lumbar cerebrospinal fluid (CSF) cytology
• Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
• Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed
• Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0)
• Peripheral absolute neutrophil count (ANC) >= 1000/uL
• Platelet count >= 100,000/uL (transfusion independent)
• Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)
• 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)
• 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)
• 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)
• >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)
• The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)
• Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
• Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L
• Central nervous system function defined as:
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
• Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment
• Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted
• All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
• Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
• Pregnancy and Breast Feeding
• Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
• Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study
Drug: Cisplatin, Drug: Cyclophosphamide, Other: Laboratory Biomarker Analysis, Drug: Lomustine, Radiation: Radiation Therapy, Drug: Vincristine, Drug: Vincristine Sulfate
Medulloblastoma
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University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Site Public Contact

Project: Every Child for Younger Patients With Cancer

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Emily Greengard
emilyg@umn.edu
All
up to 25 Years old
This study is NOT accepting healthy volunteers
NCT02402244
1603M85344
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Inclusion Criteria:

• Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem
• Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority
• Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:
• All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one "1" (borderline), two "2" (carcinoma in situ) or three "3" (malignant)
• All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant
• The following other benign/borderline conditions:
• Mesoblastic nephroma
• Teratomas (mature and immature types)
• Myeloproliferative diseases including transient myeloproliferative disease
• Langerhans cell histiocytosis
• Lymphoproliferative diseases
• Desmoid tumors
• Gonadal stromal cell tumors
• Neuroendocrine tumors including pheochromocytoma
• Melanocytic tumors, except clearly benign nevi
• Ganglioneuromas
• Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission
• If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1
Other: Cytology Specimen Collection Procedure, Other: Medical Chart Review
Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Ganglioneuroma, Lymphoproliferative Disorder, Malignant Solid Neoplasm, Melanocytic Neoplasm, Myeloproliferative Neoplasm, Neuroendocrine Neoplasm, Stromal Neoplasm
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Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Site Public Contact

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) (Limit-JIA)

To evaluate the effectiveness of a 24-week course of treatment with a T-cell co-stimulation inhibitor (abatacept (Orencia)) plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication (s) for JIA (e.g one or more of the following: glucocorticoids, DMARD or biologic) medication within 18 months of randomization in children with recent-onset limited JIA

Colleen Correll
corr0250@umn.edu
All
2 Years to 16 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03841357
STUDY00007938
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To be eligible for this trial, participants must meet all of the following criteria in order to be include in the study: 1. Age ≥ 2 years old and ≤16.5 years old 2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months 3. Arthritis affecting ≤4 joints between disease onset and randomization 4. Enrollment in the CARRA Registry 5. Participants of childbearing potential must agree to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 66 days after taking the last dose of study drug. 6. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent to participate in the Limit-JIA study. The presence of any of the following will exclude a study participant from inclusion in the study: 1. 1. Systemic JIA as defined by 2004 ILAR criteria1 2. Sacroiliitis (clinical or radiographic) 3. Inflammatory bowel disease (IBD) 4. History of psoriasis or currently active psoriasis 5. History of uveitis or currently active uveitis 6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the following: DMARD or biologic medication) 7. Current or previous (within 30 days of enrollment) treatment with systemic glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed) 8. History of active or chronic liver disease 9. Chronic or acute renal disorder 10. AST (SGOT), ALT (SGPT) or BUN >2 x ULN (upper limit of normal) or creatinine >1.5 mg/dL or any other laboratory abnormality considered by the examining physician to be clinically significant within 2 months of the randomization visit 11. Presence of any medical or psychological condition or laboratory result which would make the participant, in the opinion of the investigator, unsuitable for the study 12. Participation in another concurrent clinical interventional study within 30 days of randomization 13. Known positive human immunodeficiency virus (HIV) 14. Received a live virus vaccine within 1 month of the baseline visit 15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold TB 16. Pregnant, breast feeding, or planned breast feeding during the study duration 17. Planned transfer to non-participating pediatric rheumatology center or adult rheumatologist in the next 12 months 18. Active malignancy of any type or history of malignancy 19. Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral antibiotics within 14 days prior to screening 20. Primary language other than English or Spanish 21. Positive for Hepatitis B surface antigen or core antibody 22. <10 Kg in weight 23. If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19 exposure at screening, it is recommended that the site follow CDC guidance regarding testing and quarantine requirements. The subject can be re-screened when there is no longer concern for active infection. A subject with a positive COVID -19 test may be re-screened.
Drug: Abatacept Injection, Other: Usual Care
Juvenile Idiopathic Arthritis
Polyarthritis, abatacept, uveitis, prevention
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University of Minnesota; Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota Richard Vehe, MD

HEALEY ALS Platform Trial - Master Protocol

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. The trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The Master Protocol describes the overall framework of the platform trial, including the target population, inclusion and exclusion criteria, randomization scheme, study endpoints, schedule of assessments, trial design, the mechanism for adding and removing interventions, and the statistical methodology and recommended statistical methods for evaluating interventions. Interventions (i.e., investigational products) are tested in trial regimens. Each trial regimen is described in its own Regimen-Specific Appendix (RSA) to the Master Protocol. The RSA will describe the nature of the intervention and its mechanism of action (MoA) including the mode and frequency of administration, dosage, the specific target population (to be selected within the pre-defined subsets of the Master Protocol), additional enrollment criteria (if any), sample size, and other specific intervention-related information and assessments (safety or other assessments that may be in addition to those outlined in the Master Protocol).

David Walk
walkx001@umn.edu
All
18 Years and over
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04297683
STUDY00010021
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Inclusion Criteria:
1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria. 2. Age 18 years or older. 3. Capable of providing informed consent and complying with study procedures, in the SI's opinion. 4. Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit. 5. Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC). 6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study. 7. Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study. 8. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study. 9. Geographically accessible to the site. 10. Participants must either not take Relyvrio/Albrioza or have started Relyvrio/Albrioza ≥ 30 days prior to the Master Protocol Screening Visit
Exclusion Criteria:
1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or EKG changes). Lab abnormalities include, but are not limited to: Hemoglobin < 10 g/dL, White Blood Cells < 3.0 x 103/mm3, Neutrophils, Absolute ≤ 1000/mm3, Eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR < 30 mL/min/1.73m2, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L. 2. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion. 3. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. 4. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit. 5. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational). 6. If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment. 7. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment. 8. Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion. 9. If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.
Drug: Zilucoplan, Drug: Verdiperstat, Drug: CNM-Au8, Drug: Pridopidine, Drug: SLS-005 Trehalose, Drug: ABBV-CLS-7262, Drug: DNL343
Amyotrophic Lateral Sclerosis
ALS, Placebo-Controlled, Double-Blind, Master Protocol, Lou Gehrig's Disease
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Essentia Health — Duluth, Minnesota Brent Gavin - (Brent.Gavin@essentiahealth.org)
University of Minnesota/Twin Cities ALS Research Consortium — Minneapolis, Minnesota Valerie Ferment - (ferm0016@umn.edu)

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglio-neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Emily Greengard
emilyg@umn.edu
All
up to 30 Years old
This study is NOT accepting healthy volunteers
NCT00904241
0807M39682
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Inclusion Criteria:

• All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
• There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
• Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
• Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
• It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
• Exceptions
• In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
• For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
• For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
• Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
• Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:

• Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis
Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
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Location Contacts
Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota Site Public Contact - (helpdesk@childrensoncologygroup.org)
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Site Public Contact - (helpdesk@childrensoncologygroup.org)

Study of Kidney Tumors in Younger Patients

• To classify patients (< 30 years old) with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight and loss of heterozygosity for chromosomes 1p and 16q, to thereby define eligibility for a series of therapeutic studies. • To maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists.

Emily Greengard
emilyg@umn.edu
All
up to 29 Years old
This study is NOT accepting healthy volunteers
NCT00898365
0708M15261
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Inclusion Criteria:

• Patients with the first occurrence of any tumor of the kidney identified on CT scan or MRI are eligible for this study; histologic diagnosis is not required prior to enrollment but is required for all patients once on study
• Eligible tumors include (but are not limited to):
• Nephroblastic tumors
• Nephroblastoma (Wilms' tumor) (favorable histology, anaplasia [diffuse, focal])
• Nephrogenic rests and nephroblastomatosis
• Cystic nephroma and cystic partially differentiated nephroblastoma
• Metanephric tumors (metanephric adenoma, metanephric adenofibroma, metanephric stromal tumor)
• Mesoblastic nephroma (cellular, classic, mixed)
• Clear cell sarcoma
• Rhabdoid tumor (any malignant rhabdoid tumor occurring outside the central nervous system [CNS])
• Renal epithelioid tumors of childhood (papillary renal cell carcinoma, medullary renal cell carcinoma, renal tumors associated with Xp11.2 translocations, oncocytic renal neoplasms after neuroblastoma)
• Angiolipoma
• Ossifying renal tumor of infancy
• Patients with the first occurrence of the following tumors are also eligible:
• Extrarenal nephroblastoma or extrarenal neprogenic rests
• Malignant rhabdoid tumor occurring anywhere outside the central nervous system
• Required specimens, reports, forms, and copies of imaging studies must be available or will become available for submission and the institution must intend on submitting them as described in the protocol procedures
• For ALL patients, (with exception of bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy***), the following submissions are required:
• A complete set of recut hematoxylin and eosin (H & E) slides (including from sampled lymph nodes, if patient had upfront nephrectomy)
• * Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed favorable histology Wilms tumor [FHWT] patients discovered to have diffuse anaplastic Wilms tumor [DAWT] at delayed nephrectomy and plan to enroll at delayed nephrectomy)
• Representative formalin-fixed paraffin-embedded tissue block or if a block is unavailable, 10 unstained slides from a representative block of tumor, if available.
• Tissue must be from diagnosis, prior to any renal tumor directed chemotherapy or radiation (only exception is for presumed FHWT patients discovered to have DAWT at delayed nephrectomy and plan to enroll at delayed nephrectomy)
• Institutional pathology report, Specimen Transmittal Form, and Pre-Treatment Pathology Checklist
• Copies of images and institutional reports of CT and/or MRI abdomen and pelvis, and Pre Treatment Imaging Checklist
• Copies of images and institutional report of chest CT for all malignant tumors
• Institutional surgical report(s) and Pre-Treatment Surgical Checklist
• CRFs: Staging Checklist and Metastatic Disease Form (if metastatic disease is noted on imaging)
• Patients with bilateral, bilaterally predisposed, multicentric, or unilateral tumor in solitary kidney planning to enroll without biopsy via imaging only
•these patients will not have central review or have a risk assignment issued, but may contribute to specimen banking for future research. However, if biopsy is done, tissue must be submitted as for other renal tumors, and initial risk assignment will require pathology and surgical rapid central reviews. The Specimen Transmittal Form and Pre Treatment Pathology Checklist are also needed.
• Please note: if the above required items are not received within 120 days of study enrollment, the patient will be considered off study
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis
Adult Cystic Nephroma, Anaplastic Kidney Wilms Tumor, Angiolipoma, Cellular Congenital Mesoblastic Nephroma, Classic Congenital Mesoblastic Nephroma, Clear Cell Sarcoma of the Kidney, Congenital Mesoblastic Nephroma, Cystic Partially Differentiated Kidney Nephroblastoma, Diffuse Hyperplastic Perilobar Nephroblastomatosis, Extrarenal Rhabdoid Tumor, Kidney Medullary Carcinoma, Kidney Neoplasm, Kidney Oncocytoma, Kidney Wilms Tumor, Metanephric Adenofibroma, Metanephric Adenoma, Metanephric Stromal Tumor, Metanephric Tumor, Mixed Congenital Mesoblastic Nephroma, Ossifying Renal Tumor of Infancy, Papillary Renal Cell Carcinoma, Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Rhabdoid Tumor of the Kidney, Wilms Tumor
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Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota
University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota Site Public Contact

CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone

This is a phase II clinical trial in participants with metastatic castration sensitive prostate cancer who are still responding to hormone therapy (androgen deprivation therapy or ADT). This study is done to see if giving a course of anti-cancer drugs, carboplatin and cabazitaxel, followed by an oral drug, abiraterone, improves cancer control as measured by prostate-specific antigen (PSA) level (may indicate the presence of prostate cancer) and imaging studies (e.g. CT scan, bone scan).

Charles Ryan
ryanc@umn.edu
Male
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03934840
STUDY00006089
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Inclusion Criteria:

• Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
• Histologically confirmed prostate cancer.
• High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions).
• ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation).
• Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy.
• ECOG Performance Status 0 or 1 (see Appendix A)
• Patient has adequate bone marrow and organ function as defined by the following laboratory values:
• Absolute neutrophil count ≥ 1.5 × 10^9/L
• Platelets ≥ 100 × 10^9/L
• Hemoglobin ≥ 9 g/dl
• Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
• In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and AST <5 x ULN
• Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome.
• Sexually active males must use a condom during intercourse while taking study drugs and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method).
• Age ≥ 18 years
Exclusion Criteria:

• Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
• Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
• Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose.
• Other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti-androgens like bicalutamide).
• PSA <2.0 ng/mL at diagnosis.
• If present, peripheral neuropathy must be ≤ Grade 1
• Patients with an active second malignancy that could, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial.
• Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
• At least 4 weeks from prior therapy completion (including radiation and/or surgery) prior to starting the study treatment
• Clinically stable CNS tumor at the time of screening.
• Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement
• Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of treating investigator.
• Patient has a history of non-compliance to medical regimen or inability to grant consent.
Drug: Cabazitaxel, Drug: Carboplatin, Drug: Abiraterone, Drug: Prednisone
Prostate Cancer
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Tamy Grainger - (tgraing1@fairview.org)

Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

All
12 Years to 17 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT01908192
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Inclusion Criteria:

• Male or female subjects who are between 12 and 17 years of age inclusive
• Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0)
• Are clinically stable with residual symptoms, defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS
• An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)
• In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) are clinically unremarkable per the investigator
• Subject has a negative urine illicit drug screening test
• Subject understands and is willing to sign the Informed Assent Form (IAF) prior to study entry and agrees to be available for all the study visits
• The subject's guardian understands and is willing to sign the Informed Consent Form (ICF) prior to study entry and agrees to be available for all the study visits
• Must not be a danger to self or others and must have family support available to be maintained as outpatients
Exclusion Criteria:

• Meets the DSM-IV or -V criteria at screening for mental retardation, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders; e.g., attention-deficit hyperactivity disorder (ADHD), are allowed as long as schizophrenia is the primary diagnosis and the comorbid disorder(s) do not require medication.
• Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose
• History of epilepsy, head trauma, or neurological illness other than Tourette's syndrome
• History of allergic reaction to sodium benzoate
• Serious medical illnesses such as acute or chronic renal disease, liver failure or heart disease that, in the opinion of the investigator, may interfere with the conduct of the study.
• Current substance abuse or positive urine illicit drug screening or history of substance dependence (including alcohol, but excluding nicotine and caffeine) in the past three (3) months.
• Use of depot antipsychotics in the past six (6) months
• Inability to follow protocol
• Body Mass Index (BMI) > 35
• Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are nursing, or who do not agree to abstinence or birth control during the study
• Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
• Previous participation in an intervention trial within 30 days of randomization
• Subjects whose PANSS score has decreased more than 10 percent during the Screening Phase
Drug: NaBen®, Drug: Placebo
Schizophrenia
Sodium Benzoate, Schizophrenia, Adolescent, Antipsychotic, Anti-psychotic, NMDA, NaBen, pediatric
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University of Minnesota Medical Center - Department of Psychiatry — Minneapolis, Minnesota Sanjiv Kumra, MD - (kumra002@umn.edu)

HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

This is a prospective randomized clinical trial, to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population (children < 120 months) will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.

Christopher Moertel, MD
moert001@umn.edu
All
up to 10 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT02875314
STUDY00000427
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Inclusion Criteria:

• Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)
• Patients may not have received irradiation or chemotherapy (except corticosteroids)
• Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
• Medulloblastoma
• Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
• Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
• Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection
• CNS Embryonal Tumors:
•Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.
• Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination
• Patients must have adequate organ functions at the time of registration:
• Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert's Syndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 (two and a half) times the upper limits of institutional normal.
• Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.
• Bone Marrow Function: 1. Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = [percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils] x total white cell count. 2. Platelet Count > 100,000/µL (transfusion independent) 3. Hemoglobin > 8 gm/dL (may have received RBC transfusions).
Exclusion Criteria:

• Patients older than 10 years of age at time of diagnosis
• Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas).
• Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.
Drug: Induction, Drug: Single Cycle Intensive Chemotherapy, Drug: Tandem 3 Cycle Intensive Chemotherapy
Medulloblastoma, Central Nervous System Embryonal Tumors
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Location Contacts
Children's Hospital of Minnesota — Minneapolis, Minnesota Anne Bendel, MD - (Anne.Bendel@childrensmn.org)
Masonic Children's Hospital/University of Minnesota — Minneapolis, Minnesota Christopher Moertel, MD - (moert001@umn.edu)

Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03954574
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Inclusion Criteria:

• Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
• Written informed consent of participating subjects after being fully briefed (for prospective analysis)
Exclusion Criteria:

• Patients with incomplete hemodynamic data at rest or exercise
• Patients without sufficient follow-up data (information on survival / lung transplantation)
• advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
• advanced heart failure with pulmonary arterial wedge pressure (PAWP) > 18 mmHg at rest
• uncontrolled systemic arterial hypertension (RR values > 160/100 mmHg at rest)
• FEV1<50% predicted
• TLC<60% predicted
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
Pulmonary Circulation Diseases
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University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA — Minneapolis, Minnesota Thenappan Thenappan - (tthenapp@umn.edu)

Prospective Global Registry for the Study of Chronic Total Occlusion Intervention (PROGRESS-CTO)

All
Not specified
This study is NOT accepting healthy volunteers
NCT02061436
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Inclusion Criteria:

• Patients undergoing CTO PCI at each of the participating centers.
Exclusion Criteria:

• None
Coronary Artery Disease
chronic total occlusion, percutaneous coronary intervention
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Location Contacts
Minneapolis Heart Institute — Minneapolis, Minnesota Emmanouil S Brilakis, MD, PhD - (esbrilakis@gmail.com)
Minneapolis VA Healthcare System and University of Minnesota — Minneapolis, Minnesota Santiago Garcia, MD - (garci205@umn.edu)

A Randomized Phase II/III Study of Conventional Chemotherapy /- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

A Study of Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Hassan Alkhateeb
All
60 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-100013-P01-RST
19-001825
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Inclusion Criteria:
 

  • Diagnosis of acute myeloid leukemia (AML) based on 2017 World Health Organization (WHO) criteria excluding acute promyelocytic leukemia with PML-RARA. 
  • No activating mutation in the Fms-like tyrosine kinase-3 (FLT3) defined as a ratio of mutant to wild-type allele >= 0.05 by capillary electrophoresis or a variant allele fraction of >= 5% by next generation sequencing from either bone marrow or peripheral blood. 
  • No evidence of CNS involvement of AML.
  • No prior chemotherapy for myelodysplastic syndrome (MDS) or AML including hypomethylating agents (e.g., azacitidine and decitabine) or lenalidomide with the following exceptions: 
    • Emergency leukapheresis. 
    • Hydroxyurea.
    • Growth factor/cytokine support.
    • All-trans retinoic acid (ATRA). 
    • Single dose of intrathecal cytarabine and/or methotrexate for patients undergoing lumbar puncture to evaluate for CNS involvement.


Exclusion Criteria:

  • Patients with myeloid sarcoma without bone marrow involvement, acute leukemia of ambiguous lineage or blast transformation of chronic myelogenous leukemia (CML) are not eligible. 
Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Acute myelogenous leukemia, Cancer, Leukemia
Acute myeloid leukemia, disease, Cancer treatment, Chemotherapy, Cytarabine, Daunorubicin, Hematopoietic system, Medical Oncology, Uproleselan [USAN], cytarabine, daunorubicin
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Mayo Clinic — Rochester, MN

Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients with an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash

Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Aminah Jatoi
All
18 years and over
ERROR
This study is NOT accepting healthy volunteers
0000-100015-P01-RST
17-007786
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Inclusion Criteria:

  • Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
  • Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart ≤ 14 days of registration and continue for at least 28 days
  • Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
  • Patient must complete baseline quality of life (QOL) packet


Exclusion Criteria:

  • Patient has a prior allergy or intolerance of ketoconazole
  • Patient has an allergy or intolerance to sulfites
Drug, Drug therapy
Cancer
Cancer treatment, Eruption due to drug, Integumentary system, Malignant neoplastic disease, Medical Oncology, ketoconazole
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Mayo Clinic — Rochester, MN

International Precision Medicine Consortium for Neurooncology Research

International Precision Medicine Consortium for Neurooncology Research

Evanthia Galanis
All
18 years and over
This study is NOT accepting healthy volunteers
0000-100022-P01-RST
17-003942
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Inclusion Criteria:

  1. Participant must be suspected of having or is known to have a tumor within/of the nervous system or other disease of the nervous system
  2. Participant, or participant’s authorized legal representative, must consent to the following:
    1. Banking of previously obtained and collection of future unused tissue, blood, and skin during surgery
    2. Providing minimal risk samples just for research purposes, such as blood, buccal swab, and urine during or outside of routine medical procedure
    3. Collection of clinical information, including PHI, from medical records, scans (radiographic neuroimages), and laboratory results
    4. Linkage of clinical information to collected tissues
    5. Providing samples and records from other institutions
    6. Use of samples for the creation of cell lines, genetic testing including whole genome sequencing as well as other available sequencing techniques, research testing (techniques under development), and that samples may be stored indefinitely until used
    7. Use of data and samples to study neurologic diseases and their treatment
    8. Notification of results that may be clinically relevant via their clinician
    9. Derivative products of value may arise for which participants will not have any financial benefit
    10. Participants may withdraw from the study at any time, however data and samples already collected may not be recalled or destroyed
    11. Samples and data to be shared with outside institutions including commercial entities, but samples will never be sold


Exclusion Criteria:

  1. No exclusion criteria are specified
Brain tumor, Cancer
Cancer treatment, Medical Oncology, Neoplasm of nervous system, Nervous system
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Mayo Clinic — Rochester, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Amrit Singh
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-MAIJ
19-000587
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Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic Health System — Mankato, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Wei Ding
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-RST
19-000587
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic — Rochester, MN

Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) versus Intensity-Modulated Photon Therapy (IMRT) for the treatment of Oropharyngeal Cancer of the Head and Neck

Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Daniel Ma
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-100029-P01-RST
16-004913
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • ***Histologically documented Squamous Cell Carcinoma of the oropharynx (AJCC v7** Stage III-IV A,B).
  • *Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing).
  • If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
  • Eastern Cooperative Oncology Group (ECOG) performance status= 0, 1, or 2.
  • Negative pregnancy test for women of child bearing potential.
  • Concurrent chemotherapy.
  • Bilateral neck radiation.


Exclusion Criteria:

  • Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e., oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity).
  • Pregnant or breast-feeding females.
  • Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
    • Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device;
    • No myocardial infarction within 3 months of registration.
  • Distant metastases (AJCC v7** Stage IV C, any T, any N and M1).
  • Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent.

*    If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
**  American Joint Committee on Cancer (AJCC) 7th edition.
*** For clinically visible or radiographically diagnosed oropharynx cancer, neck mass biospy/US FNA is acceptable.

 

 

 

Behavioral, Procedure/Surgery, Radiation, Proton therapy
Cancer, Head and neck cancer, Mouth cancer, Throat cancer
Digestive system, IMRT, Medical Oncology, Proton therapy, Radiation therapy, Squamous cell carcinoma of oropharynx
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ABC-108: A Phase I/IIA Study of ABC294640 Alone and in Combination with Hydroxychloroquine Sulfate in the Treatment of Patients with Advanced, Unresectable Intra-Hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma

A Study of ABC294640 (Yeliva®) in the Treatment of Patients with Advanced Cholangiocarcinoma

Amit Mahipal
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100032-P01-RST
17-002668
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Inclusion Criteria:

  • Patients with histologically confirmed intra-hepatic, perihilar or extra-hepatic CCA.
  • Patients should not have received more than 2 prior treatment lines with systemic anti-neoplastic therapy (chemotherapy, targeted therapy etc.) for advanced or metastatic CCA. Previous adjuvant therapy, neoadjuvant or combined chemoradiotherapy for early stage disease, are not considered as part of the 2 allowed therapy lines for the purpose of this study.
  • The tumor is unresectable and not amenable to curative therapy.
  • At least 1 measurable lesion on CT scan per RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Life expectancy of at least 3 months.
  • Age ≥ 18 years.
  • Signed, written IRB-approved informed consent.
  • A negative pregnancy test (if female).
  • Serum sodium within normal limits.
  • Acceptable liver and renal function:
    • Bilirubin ≤ 1.5 times upper limit of normal (NCI-CTCAE Grade 2 baseline);
    • AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal (ULN);
    • Serum creatinine ≤ 1.5 X ULN (NCI-CTCAE Grade 1 baseline);
    • Albumin > 3.0 g/dL
  • Acceptable hematologic status:
    • Absolute neutrophil count ≥1000 cells/mm^3;
    • Platelet count ≥ 75,000 (plt/mm^3) (NCI-CTCAE Grade 1 baseline);
    • Hemoglobin ≥ 9 g/dL.
    • Acceptable blood sugar control:
      • Fasting glucose value ≤ 160 mg/dL (NCI-CTCAE Grade 1 baseline).
    • Urinalysis: No clinically significant abnormalities.
    • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT.
    • For men and women of child-producing potential, willingness to use of effective contraceptive methods during the study. If female (or female partner of male patient), was either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing one of the following medically acceptable methods of birth control and agreed to continue with the regimen throughout the duration of the study:
      • Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline/randomization visit;
      • Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline/randomization visit);
      • Intrauterine device;
      • Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream).


Exclusion Criteria:

  • > 2 previous systemic anti-neoplastic regimens for advanced/metastatic CCA.
  • Previously having received ABC294640 or HCQ (or chloroquine) for the treatment of a malignancy.
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
  • History of psychosis or anxiety disorders.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Pregnant or nursing women.
    • NOTE: If a woman became pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry. Patients who had received any antineoplastic therapy > 28 days prior to starting treatment with ABC294640 must have recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and Grade 1 neuropathy).
  • Unwillingness or inability to comply with procedures required in this protocol.
  • Known infection with human immunodeficiency virus.
  • Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
  • Patients who were currently receiving any other investigational agent.
  • Patients who were receiving drugs that are:
    • Sensitive substrates, or substrates with a narrow therapeutic range, for CYP2C8, CYP2C9, CYP2C19, CYP3A4 should be avoided, when possible, or used with caution because ABC294640 may either increase or decrease patients’ exposure to these drugs. In addition, P-gp and BCRP sensitive and/or narrow therapeutic range substrates for which safety cannot be readily monitored for should be avoided, when possible, or used with caution for the same reasons.
    • Moderate or strong inhibitors of CYP1A2, CYP3A4 or CYP2D6 or moderate to strong inducers of CYP3A4 and CYP1A2 are prohibited
  • Patients who are taking warfarin, apixaban, argatroban or rivaroxaban.
  • If the patient is to receive HCQ, pre-existing retinopathy.
  • Known history of G-6-PD Deficiency, porphyria or psoriasis.
  • History of macular degeneration, visual field changes, retinal disease, or cataracts that would interfere with funduscopic eye examinations.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
  • Corrected QT (QTc) interval on electrocardiogram (ECG) > 470 ms for females or > 450 ms for males, calculated using Friedericia’s formula (QTcF)
  • In cell culture, ABC294640 inhibited hERG potassium current, with a maximum inhibition of 71%. In dog studies, no ECG abnormalities were noted, nor has QTc prolongation been noted in human studies. However, due to the in vitro hERG results, treatment within seven days, or 5 half-lives, whichever is longer, with any medication that causes QT prolongation prior to initiation of study drug, or intention to use them throughout the study is not recommended. These medications include but not limited to: amiodarone, amitriptyline, azithromycin, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilide, pimozide, procainamide, quinidine, quinine, quinolone, ranolazine, risperidone, sotalol and tolterodine.

Eligibility last updated 9/29/21. Questions regarding updates should be directed to the study team contact.

 

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Cholangiocarcinoma
Cholangiocarcinoma, Digestive system, Medical Oncology
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Mayo Clinic — Rochester, MN

Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer (PARTIQoL)

Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Thomas Pisansky
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100033-P01-RST
16-002706
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Inclusion Criteria:

  • Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
  • Clinical stages T1c to T2b
  • PSA <20
  • Gleason score ≤6 if PSA <20 or Gleason score 3 + 4 = 7 or 4 + 3 = 7 if PSA <20
  • Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry
  • Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10


Exclusion Criteria:

  • Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
  • Prior or planned androgen deprivation or bilateral orchiectomy
  • Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
  • Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
  • History of other malignancies within the past 5 years
  • Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
  • Major medical or psychiatric illness
Radiation
Cancer, Prostate cancer
External beam radiation for prostate cancer, IMRT, Medical Oncology, Proton therapy, Radiation therapy, Reproductive system
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Mayo Clinic — Rochester, MN

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAB001 in Subjects With Advanced Malignancies

A Study to Determine the Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

Amit Mahipal
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100041-P01-RST
18-006869
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Inclusion Criteria:
 

  • Signed Informed Consent Form.
  • Age ≥ 18 years.
  • Subject meets the following corresponding requirements for the part of the study they will enroll into:
    • During Part A, subjects must have a histologically or cytologically documented, incurable or metastatic solid tumor that has progressed on (or they have been intolerant to) standard systemic therapy options for their tumor type in the metastatic setting or must have a tumor type for which no such standard systemic option exists.
    • During Part B, subjects must have a histologically or cytologically documented diagnosis of esophageal or gastric carcinoma, cholangiocarcinoma, neuroendocrine tumor (NET) of the gastrointestinal tract and pancreas, sarcomas, both soft tissue sarcoma (excluding leiomyosarcoma) and chondrosarcoma, or with agreement of the Sponsor, other tumors (including NPC and HCC) that have been treated with at least one line of standard systemic therapy for their respective tumor type in the metastatic setting with progressive locally advanced or metastatic disease that is not amenable to definitive local therapy with curative intent. Patients with MSI-H/dMMR tumors are eligible to enroll:
      • Subjects with nasopharyngeal cancer must have received (or been intolerant to) to a platinum-based combination as part of their prior therapy for advanced/metastatic disease;
      • Subjects with soft tissue sarcoma and chondrosarcoma must have radiographic evidence of progression within the previous 6 months and must have received at least 1 line of systemic therapy;
      • Subjects with esophageal cancer must have received (or been intolerant to) platinum-based combination as part of their prior therapy for advanced/metastatic disease;
      • Subjects with gastric cancer must have received (or been intolerant to) a fluoropyrimidine-platinum combination as part of their prior therapy for advanced/metastatic disease;
      • Subjects with HCC must have received (or been intolerant to) sorafenib as part of their prior therapy for advanced metastatic disease.
  • Measurable disease per RECISTv1.1 and irRECIST.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ and marrow function, as defined below:
    1. Hemoglobin ≥ 8.0 g/dL within first 2 weeks prior to first dose of toripalimab;
    2. Absolute neutrophil count (ANC) ≥ 1.2 x 10^9/L (1,200/mm^3);
    3. Platelet count ≥ 75 x 10^9/L (75,000/mm^3);
    4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) except subjects with documented Gilbert’s syndrome who must have a baseline total bilirubin ≤ 3.0 mg/dL;
    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for subjects with hepatic metastases, ALT and AST ≤ 5 × ULN;
    6. Serum creatinine ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) or 24-hour urine CrCl ≥ 40 mL/minute;
    7. Cockcroft-Gault formula will be used to calculate CrCl.(9.4); 24-hour urine CrCl will be derived using the measured creatinine clearance formula (9.5);
    8. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; applies only to subjects who do not receive therapeutic anticoagulation; subjects receiving therapeutic anticoagulation (such as low-molecular weight heparin or warfarin) should be on a stable dose.
  • Willingness to provide consent for biopsy samples (In Part A, fresh pre-treatment biopsies will be requested from subjects with safely accessible lesions. For subjects who cannot provide a fresh pre-treatment biopsy, an archival specimen will be required. In Part B, fresh pre-treatment biopsies will be required from subjects with safely accessible lesions. Archival specimens will be requested).
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use effective contraception from time of screening, and must agree to continue using such precautions for 90 days after the final dose of toripalimab; cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal  ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as at least 12 months with no menses confirmed by follicle-stimulating hormone [FSH] levels. FSH testing will be conducted at the Screening visit to confirm post-menopausal status).
  • Subjects must use effective contraception as described in below:
    • Barrier Methods
      • Male condom plus spermicide;
      • Copper T intrauterine device;
      • Levonorgestrel-releasing intrauterine system;
      • (e.g., MirenaR)*
      • * this is also considered a hormonal method.
    • Hormonal Methods
      • Implants;
      • Hormone shot or injection;
      • Combined pill;
      • Minipill;
      • Patch.
  • Nonsterilized males who are sexually active with a female partner of childbearing potential must use effective contraception from Day 1 and for 90 days after receipt of the final dose of toripalimab.


Exclusion Criteria:
 

  • Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
    • NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy).
  • Receipt of any investigational anticancer therapy within 4 weeks prior to the first dose of toripalimab.
  • Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of toripalimab, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids not to exceed 10 mg/day of prednisone or equivalent.
  • In Part A: Prior exposure to immunotherapy such as but not limited to other anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies excluding vaccines.
  • In Part B: Exclusion of prior immunotherapy exposure will be limited to anti-PD-1, anti-PD-L1, or anti-PD-L2.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Major surgery (as defined by the investigator) within 4 weeks prior to first dose of toripalimab or still recovering from prior surgery.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to baseline or to NCI-CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by toripalimab may be included (e.g., hearing loss) after consultation with the medical monitor.
  • Active or prior documented autoimmune disease within the past 2 years.
    • NOTE: Subjects with vitiligo, Grave’s disease not requiring systemic treatment other than thyroid hormone replacement (within the past 2 years), or psoriasis not requiring systemic treatment are not excluded. Subjects with a history of autoimmune hypothyroidism requiring only thyroid hormone replacement therapy will not be excluded.
  • Known history of tuberculosis.
  • Subjects who are known to be human immunodeficiency virus (HIV) positive.
  • Subjects with evidence of hepatitis B or C virus infection, unless their hepatitis is considered to have been cured. (Note that subjects with prior hepatitis B virus [HBV] infection must have HBV viral load [VL] <100 IU/mL before study enrollment, and must be treated according to local standards; hepatitis C virus [HCV] infection must have, before study enrollment, no detectable VL and must be treated according to local standards).
  • Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).
  • History of primary immunodeficiency.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure according to New York Heart Association (NYHA) Functional Classification ≥3, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs from toripalimab, or compromise the ability of the subject to give written informed consent.
  • Symptomatic or untreated central nervous system metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no evidence of new or enlarging metastases, and are off steroids.
  • Receipt of live attenuated vaccination within 4 weeks prior to study entry or within 4 weeks of receiving toripalimab.
  • Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of toripalimab or interpretation of subject safety or study results.
  • Pregnant or breastfeeding women.

 

Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy
Cancer, Endometrial cancer, Esophageal cancer, Nasopharyngeal carcinoma, Sarcoma, Soft tissue sarcoma, Stomach cancer
Cancer treatment, Carcinoma of esophagus, Carcinoma of stomach, Digestive system, Medical Oncology, Musculoskeletal system, Nasopharyngeal carcinoma, Primary malignant neoplasm of endometrium, Reproductive system, Respiratory system, Sarcoma of soft tissue, Secondary malignant neoplastic disease
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Mayo Clinic — Rochester, MN

CO-338-063 TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency (TRITON3)

A Study of Rucaparib Verses Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

J Quevedo
Male
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100060-P01-RST
17-003810
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Inclusion Criteria:

  • Male ≥ 18 years of age at the time the informed consent form is signed.
  • Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (pure small-cell histologies or pure high-grade neuroendocrine histologies are excluded; neuroendocrine differentiation is allowed) that is metastatic.
  • Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM). If currently being treated with luteinizing hormone–releasing hormone (LHRH) analogs (patients who have not undergone an orchiectomy), therapy must be continued throughout the study.
  • Eligible for treatment with physician’s choice of comparator treatment, selected prior to randomization, per the corresponding prescribing information.
  • Evidence of disease progression after treatment with one prior next-generation AR-targeted therapy (abiraterone acetate, enzalutamide, apalutamide, or investigational AR-targeted agent); treatment with the older anti-androgen therapies such as bicalutamide, flutamide, and nilutamide are not counted toward this limit.
  • Disease progression after initiation of most recent therapy is based on any of the following criteria:
    • Rise in PSA: a minimum of two consecutive rising levels, with an interval of ≥ 1 week between each determination. The most recent screening measurement must have been ≥ 2 ng/mL;
    • Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by modified RECIST Version 1.1;
    • Radionuclide bone scan: at least two new metastatic lesions.
  • All patients must have a deleterious gene mutation in BRCA1/2 or ATM. Mutations may be identified by local testing or through central testing by the sponsor of plasma or tumor tissue.
  • For local test results, the classification of the mutation as deleterious must be documented in the patient’s medical record.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Have adequate organ function confirmed by the following clinical laboratory values obtained within 14 days prior to the first dose of study drug:
    • Bone Marrow Function i. ANC ≥ 1.5 × 109/L:
      • Platelets > 100 × 109/L;
      • Hemoglobin ≥ 10 g/dL independent of transfusion within 14 days.
    • Hepatic Function:
      • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × the upper limit of normal (ULN);
      • Bilirubin ≤ 1.5 × ULN (< 2 x ULN if hyperbilirubinemia is due to Gilbert’s syndrome).
    • c. Renal Function:
      • Estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft-Gault formula.
  • Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of study drug for the time period specified:
    • Use a condom during sex while being treated and for 3 months after the last dose of study drug;
    • Do not make semen donations during treatment and for 3 months after the last dose of rucaparib;
    • Those with female partners of childbearing potential may be enrolled if they are:
      • Documented to be surgically sterile (ie, vasectomy);
      • Committed to practicing true abstinence during treatment and for 3 months after the last dose of study drug; or
      • Committed to using a highly effective method of contraception (refer to Section 6.5) with their partner during treatment and for 3 months following the last dose of study drug.
  • Have a life expectancy of at least 6 months.


Exclusion Criteria:

  • Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer:
    • Patients with a history of malignancy that has been completely treated, and currently with no evidence of that cancer, are permitted to enroll in the study provided all therapy was completed > 6 months prior and/or bone marrow transplant (BMT) > 2 years prior to first dose of rucaparib.
  • Prior treatment with any PARPi.
  • Prior treatment with chemotherapy (eg docetaxel, mitoxantrone, cyclophosphamide, platinum-based agents) for mCRPC. Prior treatment with docetaxel (or other taxane chemotherapy) administered for castration-sensitive disease is permitted .
  • Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with asymptomatic, previously treated CNS metastases are eligible provided they have been clinically stable (not requiring steroids for at least 4 weeks prior to first dose of study drug) and have appropriate scans at screening assessment.
  • Symptomatic or impending spinal cord compression unless appropriately treated, clinically stable, and asymptomatic.
  • Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug.
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C, with the exception of patients with sustained virologic response after completion of treatment for hepatitis C.
  • Received treatment with chemotherapy, antibody therapy, immunotherapy, gene therapy, angiogenesis inhibitors, or experimental drugs within < 14 days prior to first dose of study drug. Treatment with hormonal therapies (with the exception of LHRH analog) must be discontinued at least 7 days prior to the first dose of study drug.
  • Adverse effect of prior therapy not resolved to CTCAE Grade 1 or below with the exception of alopecia. Ongoing Grade 2 non-hematologic toxicity related to most recent treatment regimen may be permitted with prior advanced approval from the sponsor.
  • Initiated low-dose corticosteroid, bisphosphonate, or denosumab therapy or adjusted low-dose corticosteroid, bisphosphonate, or denosumab dose/regimen within < 28 days prior to first dose of study drug. Patients on a stable low-dose corticosteroid, bisphosphonate, or denosumab regimen are eligible and may continue treatment.
  • Non-study related minor surgical procedure within < 5 days, or major surgical procedure within < 21 days, prior to first dose of study drug; in all cases, the patient must be sufficiently recovered and stable before treatment administration.
  • Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.

 

 

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Prostate cancer
Abiraterone, Hormone refractory prostate cancer, Medical Oncology, Reproductive system, abiraterone, docetaxel, enzalutamide, rucaparib
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Genomically-Guided Treatment Trial in Brain Metastases

A Study to Evaluate Genetic Testing in Guiding Treatment for Patients with Brain Metastases

Sani Kizilbash
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100069-P01-RST
19-010598
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Inclusion Criteria:

PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).

REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)

  • Participants must have histologically confirmed metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease. 
  • New or progressive brain metastases are defined as any one of the following: 
    • Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions; 
    • Residual or progressive lesions after surgery if asymptomatic; 
    • Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression;
    • Patients who have not previously been treated with cranial radiation (e.g., WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases. 
  • Measurable CNS disease (> 10 mm). 
  • Ability to obtain magnetic resonance imaging (MRI)s. 
  • No surgery within 2 weeks prior to or after registration.
  • No chemotherapy within 14 days prior to registration
    • Note: for abemaciclib arm, a 21-day chemotherapy washout is required).
    • For melanoma, patients must have progressed after prior immune checkpoint blockade or for BRAF positive melanoma, BRAF/MEK inhibitors.
    • For lung cancer, EGFR mutant patients must have failed EGFR therapies
    • For HER2-positive breast cancer patients, patients must have received at least one prior HER-2 directed therapy in the metastatic setting.
    • For triple negative breast cancer (TNBC), patients must have received at least one chemotherapy in the metastatic setting. 
    • For estrogen receptor (ER)/progesterone receptor (PR)+ breast cancer, patients must have received at least one endocrine therapy in the metastatic setting. 
    • Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib.
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy that was resected as part of clinical care). If the patient does not have any evidence of extracranial disease, brain metastasis tissue is sufficient for eligibility.
  • Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site. 
  • Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
    • Note: for abemaciclib arm, pregnancy test is required ≤ 7 days prior to registration.
    • No known leptomeningeal involvement. 
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function.
    •Absolute neutrophil count (ANC) ≥ 1,500/mm^3.
  • Platelet count ≥ 100,000/mm^3. 
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except in patients with Gilbert's disease. 
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN). 
  • Creatinine ≤ 1.5 mg/dL OR calculated (Calc.) creatinine clearance > 45 mL/min. 
  • No uncontrolled medical comorbidities per investigator discretion (e.g., interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Concurrent radiation to symptomatic non-target sites within neural axis is allowed (provided there is at least one untreated target lesion). 
  • Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration. Baseline doses and changes in steroid dosing will be captured. 
  • No concurrent administration of anticancer therapies (except for endocrine therapy or continuation of hormonal therapy or trastuzumab in breast cancer patients). No chemotherapy, targeted therapy or immunotherapy within 14 days prior to entering the study
    •  Note: For abemaciclib arm, a 21-day chemotherapy washout is required. 
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR GDC-0084 ARM

  • Urine protein to creatinine (UPC) ratio < 1 or urine protein ≤ 1. 
  • Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded. Patients with symptomatic bradycardia should have an electrocardiogram at baseline. If QT interval > 470 msec, the patient is excluded. 
  • Patients with uncontrolled type I or II diabetes mellitus should be excluded. Uncontrolled diabetes is defined as glycosylated hemoglobin (HbA1c) > 9% in addition to fasting glucose > 140 mg/dL on at least 2 occasions within 14 days prior to registration.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ENTRECTINIB ARM

  • Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.

ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM

  • Hemoglobin ≥ g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. 
  • Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy). 
  • Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration. 
  • For females of childbearing potential: A female of childbearing potential, must have a negative serum pregnancy test within 7 days prior to registration and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. 
  • Patients with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive] are excluded. Screening is not required for enrollment.
  • Patients with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest, are excluded.
Drug, Genetic
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Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy

Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy

Bradley Leibovich
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100084-P01-RST
17-004167
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of UC of the bladder, with:
    • histologic confirmation of the primary UC pathology;
    • indication for RC;
    • ineligibility for platinum-based neoadjuvant chemotherapy. This may be due to (i) patients not being indicated for neoadjuvant chemotherapy due to noninvasive disease; (ii) not eligible for neoadjuvant chemotherapy due to safety concerns, contraindications, or comorbidities OR (iii) patients refused neoadjuvant chemotherapy.
  • ECOG Performance Status (PS) 0 or 1.
  • Ability to provide informed consent.
  • Willingness to comply with all required protocol procedures including providing biologic specimens and returning to the clinical study site for follow up visits.
  • Performance status sufficient to undergo RC (in the opinion of the enrolling urologist).
  • The following laboratory values obtained ≤ 14 days prior to study day 1:
    • ANC ≥ 1500/mm^3;
    • Platelets ≥ 100,000/mm^3;
    • HgB > 9.0 g/dL;
    • Total bilirubin ≤ institutional upper limit of normal (ULN);
    • SGOT (AST) ≤ 1.5 x ULN;
    • Creatinine clearance ≥ 30 ml/min.
  • Must be willing to implement contraception throughout the study and for 8 weeks after intravesical administration of MV-NIS.


Exclusion Criteria:

  • Variant UC pathology (defined as > 25% variant histology in the diagnostic bladder biopsy), including but not limited to micropapillary, signet ring, sarcomatoid, UC with squamous differentiation and clear cell variants.
  • Patients with any other prior malignancy are not allowed except for the following:
    • History of or concurrent non-invasive UC involving a portion of urinary tract outside of the bladder;
    • Adequately treated basal cell or squamous cell skin cancer;
    • In situ cervical cancer;
    • Adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Any of the following prior therapies:
    • Chemotherapy ≤ 3 weeks prior to study day 1;
    • Biologic therapy ≤ 4 weeks prior to study day 1;
    • Radiation therapy ≤ 3 weeks prior to study day 1;
    • Investigational therapy ≤ 4 weeks prior to study day 1.
  • Failure to fully recover from acute, reversible effects defined as ≤ grade 1 CTCAE v.4.03 of prior systemic therapy regardless of interval since last treatment.
  • Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks after intravesical administration of MV-NIS.
  • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • History of organ transplantation.
  • Requiring blood product support.
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus (HIV1 or 2) indicating acute or chronic infection.
  • Active infection (any grade) ≤ 5 days prior to study day 1.
  • Active TB infection.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Current exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency.
  • Unwillingness to avoid household contacts ≤ 15 months old or household contact with known immunodeficiency 1 week after treatment.
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
  • Allergy to iodine.
    • Note: This does not include reactions to intravenous contrast materials.

 

 

Biologic/Vaccine, Administration of antineoplastic agent, Administration of substance into bladder via intravesical route, Drug therapy, Radical cystectomy
Bladder cancer, Cancer
Bladder removal, Medical Oncology, Transitional cell carcinoma of bladder, Urinary system
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Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Robert Mutter
All
21 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100096-P01-RST
15-009538
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Inclusion Criteria:

  • Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
  • For patients who have undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed.
  • For patients who have undergone lumpectomy, there are no breast size limitations.
  • Patients with non-metastatic breast cancer are eligible. This includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis. For patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible.
  • Bilateral breast cancer is permitted. Patients with bilateral breast cancer will be stratified as left-sided.
  • Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
  • Must have a pertinent history/physical examination within 90 days prior to registration.
  • Age ≥ 21 years
  • Negative pregnancy test by urine or serum or waiver of pregnancy testing per local institutional policy within 30 days prior to randomization according to local standards for women of childbearing potential.
  • ECOG Performance Status 0
    •2 (asymptomatic to symptomatic but capable of self-care) within 45 days prior to randomization.
  • Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.
  • Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing is not required for eligibility for this protocol.
  • The patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution.
  • Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible.
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
  • Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma.
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Behavioral, Radiation, Assessment of quality of life, Proton therapy, X-ray beam therapy
Breast cancer, Cancer, Invasive lobular carcinoma, Male breast cancer
Breast cancer surgery, Cancer treatment, History of mastectomy, Infiltrating duct carcinoma of breast, Infiltrating lobular carcinoma of breast, Lumpectomy, Malignant neoplasm of female breast, Malignant neoplasm of male breast, Mastectomy, Medical Oncology, Proton therapy, Radiation therapy, Radiation therapy for breast cancer
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(ECTx) APL-101-01 (SPARTA): Phase 1/2 Multicenter Study of Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 skip mutations and c-Met Dysregulation Advanced Sol (SPARTA)

A Study of Subjects with NSCLC with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Sani Kizilbash
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100132-P01-RST
17-005399
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Inclusion Criteria:
 

  • Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
  • Men and women 18 years of age or older.
  • For Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy.
  • For Phase 2, five cohorts will be enrolled:
    • Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve) for first line treatment;
    • Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve) pretreated subjects with no more than 3 lines of prior therapy in the metastatic setting;
    • Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met inhibitor);
    • Cohort C: basket of tumor types with c-Met high level amplification (NSCLC EXON 14 skip mutation excluded);
    • Cohort D: basket of tumor type with c-Met fusions.
  • Cohort A-1: EXON 14 Non-small-Cell Lung Cancer – c-Met inhibitor naïve:
    • Histologically or cytologically confirmed NSCLC with EXON 14 skip mutations as determined by MI Transcriptome™ companion diagnostic (CDx) by central laboratory, Caris Life Sciences;
    • All histologies, including pulmonary sarcomatoid carcinoma and squamous;
    • Unresectable or metastatic disease (Stage 3b/4);
    • Treatment naïve subjects in first line;
    • Not received any c-Met inhibitor (e.g., crizotinib, capmatinib, savolitinib, etc.).
  • Cohort A-2: EXON 14 Non-Small-Cell Lung Cancer – c-Met inhibitor naïve (≥ 2L):
    • Histologically or cytologically confirmed NSCLC with EXON 14 skip mutations;
    • All histologies, including pulmonary sarcomatoid carcinoma and squamous;
    • Unresectable or metastatic disease (Stage 3b/4);
    • Pretreated subjects refractory to or intolerable to standard therapies with no more than three lines of prior therapy in the metastatic setting;
    • Not received any c-Met inhibitor (e.g., crizotinib, capmatinib, savolitinib, etc.).
  • Cohort B: EXON 14 Non-Small-Cell Lung Cancer – c-Met inhibitor experienced:
    • Histologically or cytologically confirmed NSCLC with EXON 14 skip mutations; 
    • All histologies, including pulmonary sarcomatoid carcinoma and squamous;
    • Unresectable or metastatic disease (Stage 3b/4);
    • Refractory to standard therapies with no more than three prior lines of therapy in the metastatic setting.
  • Cohort C: Basket Tumor Types (c-Met high-level amplifications):
    • Any tumor type regardless of histology, including osimertinib relapsed/refractory NSCLC, excluding NSCLC EXON 14 skip mutation, that meets inclusion criteria c-Met high-level amplification;
    • Unresectable or metastatic disease, refractory to or intolerant of standard therapies, or refused standard therapies, or if therapy was unavilable or unfeasible, with no more than three prior lines of therapy in the metastatic setting;
    • Not received any c-Met inhibitor (e.g., crizotinib, capmatinib, savolitinib, etc.).
  • Cohort D: Basket Tumor Types (c-Met fusions):
    • Any other tumor type histology that meets inclusion criteria c-Met fusions;
    • Unresectable or metastatic disease, refractory to or intolerant of standard therapies. or refused standard therapies, or if therapy unavailable or unfeasible, with no more than three prior lines of therapy in the metastatic setting;
    • Not received any c-Met inhibitor (e.g., crizotinib, capmatinib, savolitinib, etc.).
  • Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from archival/local results or molecular pre-screening evaluations. 
  • Phase 1 (100, 200, and 300 mg Cohorts):
    • c-Met overexpression by IHC 2+ ≥ 50% of tumor cells; or
    • c-Met amplification (c-Met/Cep-7 ratio ≥ 2.2 or GCN ≥ 6 gene copy); or
    • c-Met EXON 14 skip mutation per NGS or RT-PCR; or
    • c-Met fusions including the following, but not limited to: BAIAP2L1-MET; C8orf34- MET; CAPZA2-MET; DCTN1-MET; EPS15-MET; LRRFIP1-MET; MET-MET; OXR1- MET; PPFIBP1-MET; PTPRZ1-MET; TFG-MET; TPR-MET; TRIM4-MET; ZKSCAN1- MET; KIF5B-MET and any other known c-Met activating mutations.
  • Phase 1 (400 mg Cohort) and Phase 2 RP2D:
    • c-Met high-level amplification (c-Met/Cep-7 ratio of ≥ 2.2 or GCN of ≥ 6 copy). A minimum of five subjects of the high-level amplification (c-Met/Cep-7 ratio of ≥ 5 or GCN ≥ 10 gene copy) for the Stage 1 of the Simon 2 stage design is required); or
    • c-Met EXON 14 skip mutation per NGS; or
    • c-Met fusions including the following, but not limited to: BAIAP2L1-MET; C8orf34- MET; CAPZA2-MET; DCTN1-MET; EPS15-MET; LRRFIP1-MET; MET-MET; OXR1- MET; PPFIBP1-MET; PTPRZ1-MET; TFG-MET; TPR-MET; TRIM4-MET; ZKSCAN1- MET; KIF5B-MET; or
    • other c-Met mutations in Dose Escalation (400 mg Cohort).
  • Local/archival result of a positive c-Met dysregulation is required (except in Cohort A-1 in US). In Phase 2, Cohorts A-2 and D require provision of tumor tissue samples (archival or fresh tumor biopsy) either from the primary or a metastatic site. For Cohorts B and C, provision of tumor tissue (archival or fresh tumor biopsy) or blood (plasma) sample for entry is acceptable.
  • In Phase 2, treated or untreated asymptomatic parenchymal CNS disease or leptomeningeal disease is allowed. 
  • Measurable disease according to RECIST v1.1 (or relevant criteria per tumor type).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0–1.
    • Acceptable organ function, as evidenced by the following laboratory data during Screening period: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
    • Total serum bilirubin ≤ 1.5 x ULN;
    • For subjects with liver metastases: Total bilirubin ≤ 3.0 x ULN, AST/ ALT ≤ 5 x ULN;
    • Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3 (1.5 x 10^9 /L); 
    • Platelet count ≥ 100,000 cells/mm^3 (100 x 10^9 /L);
    • Serum creatinine levels ≤ 1.5 ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min as calculated by the Cockcroft-Gault method;
    • Hemoglobin ≥ 9 g/dL.
  • For all prior anticancer treatment, including radiotherapy, chemotherapy, or targeted agents or hormonal therapy, a duration of 30 days or 5 half-lives of the agents used, whichever is shorter, must have elapsed, and any encountered toxicity must have resolved to levels meeting all the other eligibility criteria prior to the first dose of study treatment. Palliative radiotherapy to non-target lesions should be completed within 2 weeks prior to APL-101 administration.
  • Adequate cardiac function (≤ NYHA class II) or normal cardiac function with left ventricular ejection fraction (LVEF) ≥ 50% at screening.
  • Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status. Post-menopausal status is defined as any of the following: natural menopause with menses > 1 year ago; radiation or chemotherapy inducted oophorectomy with menses > 1 year ago and follicle stimulating hormone (FSH) level in the menopausal range.
  • All subjects with reproductive potential must agree, and site must document as such, the use of effective contraceptive measures (e.g., oral contraceptives, intrauterine device, or double barrier method of condom and spermicide) during the study and for 7 months (WOCBP) or 4 months (men) following the last dose of study drug.
    • Notes: A postmenopausal woman will be defined as having no menses for 12 months without an alternative medical cause. Male sterility will be defined as only men sterilized surgically. For male subjects with a pregnant partner, a condom should be used for contraception. For male subjects with a non-pregnant female partner of child-bearing potential and woman of childbearing potential one of the following birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended:
    • Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally;
    • Progesterone-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant;
    • Intrauterine device (IUD);
    • Intrauterine hormone-releasing system (IUS);
    • Bilateral tubal occlusion;
    • Vasectomized partner;
    • Sexual abstinence (considered a highly effective method only if defined as refraining from hetersexual intercourse during the entire period of risk associated with the study treatment. The reliabiity of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
  • Birth control methods unacceptable for this clinical trial are:
    • Periodic abstinence (calendar, symptothermal, or post-ovulation methods);
    • Withdrawal (coitus interruptus);
    • Spermicide only;
    • Lactational amenorrhea method.
  • Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade ≤ 1, except for alopecia.
  • No planned major surgery within 4 weeks of first dose of APL-101.
  • Willing and able to participate in all required evaluations and procedures in this study including swallowing APL-101 in accordance administration schedule outlined.


Exclusion Criteria:

  • Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known actionable mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
  • Use or intended use of any other investigational product, including herbal medications, through Study Treatment Termination.
  • Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process, which in the opinion of the investigator makes the risk:benefit unfavorable for the participation of the trial. Screening for chronic conditions is not required.
  • Life-threatening illness, significant organ system dysfunction or comorbid conditions, or other reasons that, in the investigator’s opinion, could compromise the subject’s safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of APL-101.
  • Unstable angina or myocardial infarction within 1 year prior to first dose of APL-101, symptomatic or unstable arrhythmia requiring medical therapy, history of congenital prolonged QT syndrome, prolonged QT interval corrected by Fridericia formula (QTcF) at screening (> 450 msec based on the average of 3 measurements), or concurrent treatment with a medication that is a known risk for prolonging the QT interval.  Concomitant Therapy). Chronic controlled atrial fibrillation is not excluded.
  • Historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) with high viral loads not actively managed with antiviral therapy and human immunodeficiency virus (HIV) positive patients who are not clinically stable or on). If history is unclear, a test at Screening will be required.
  • Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
  • Unable to swallow orally administered medication whole.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  • Women who are breastfeeding.
  • Subjects with complications from prior radiation therapy will not be eligible until AEs return to baseline or ≤ Grade 1.
  • History of another malignancy within 3 years prior to Cycle 1 Day 1. A subject with the following malignancies is eligible for this study if, in the opinion of the Investigator, they do not pose a significant risk to life expectancy:
    • Carcinoma of the skin without melanomatous features;
    • Curatively treated cervical carcinoma in situ;
    • Bladder tumors considered superficial such as noninvasive (TIa) and carcinoma in situ (TIs), thyroid papillary cancer with prior treatment, prostate cancer which has been surgically or medically treated and not likely to recur within 3 years.
  • Subjects who are unable or unwilling to discontinue excluded mediciations for at least 5 half-lives prior to first dose of study drug.
  • Subjects with active COVID-19 infection.

Eligibility last updated 9/9/21. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Kidney cancer, Stomach cancer
Carcinoma of stomach, Digestive system, Malignant neoplasm of cardio-esophageal junction of stomach, Medical Oncology, Renal cell carcinoma, Urinary system
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HCRN-CUP16-268: Single-arm Phase 2 Study to Examine Pembrolizumab and Concurrent Radiation to Induce an Abscopal Effect in Patients With Previously Treated Carcinoma of Unknown Primary (CUP16-268) (HCRN-CUP16-268)

Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary

Harry Yoon
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100151-P01-RST
17-006678
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Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • ECOG Performance Status of ≤ 2 within 28 days prior to registration
  • Archival tissue must be available and identified during screening and shipped prior to Day -21. If archival tissue is not available and the subject is not undergoing a standard of care biopsy, the subject must undergo a research biopsy to obtain fresh tissue prior to start of treatment.
  • Carcinoma of unknown primary after the following diagnostic procedures have been performed if clinically indicated and are unrevealing of the primary site:
    • Complete history and clinically appropriate physical
    • CT scan of chest, abdomen, and pelvis
    • Directed evaluation of symptomatic areas
    • Mammogram in women
    • Colonoscopy in patients with liver metastasis or an elevated CEA
    • Direct pathologic comparison with prior tumor specimens, where possible, even if prior tumor is early-stage or clinically remote from current disease
  • Histologic confirmation of metastatic adenocarcinoma, poorly differentiated non-small cell carcinoma, or poorly differentiated squamous carcinoma. NOTE: Pathology consultation at Mayo Clinic is recommended if clinically indicated. One scenario is where unknown primary is the most likely diagnosis but immunostains show relatively site-specific marker staining (e.g., CD45, TTF1, chromogranin, GATA3, PAX8, PSA, melanocytic markers). Information provided for pathology consultation should include recent H&P and imaging reports.
  • If available, submission of genomic sequencing or expression profiling results is mandatory.
  • At least one measurable lesion (per RECIST 1.1) outside the planned RT fields.
  • Stable or progressive disease after, or was unable to tolerate, at least one line of prior anticancer therapy for this disease. NOTE: For patients with stable disease, it is strongly encouraged to confirm the presence of active disease (eg, demonstrating FDG avidity via PET or repeat biopsy).
  • Radiation oncology consultation at enrolling site ≤ 56 days prior to registration to confirm at least two metastatic lesions which are targetable by RT at doses and schedule prescribed in this study and which reside in non-overlapping RT fields.
  • Absolute Neutrophil Count (ANC) ≥ 900 K/mm3
  • Hemoglobin (Hgb) ≥ 8.5 g/dL without transfusion or EPO dependency (≤ 7 days prior to assessment)
  • Platelets ≥ 90,000 / mcL
  • Creatinine OR Calculated creatinine clearance: ≤ 1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
  • Bilirubin Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN OR total bilirubin ≤2 X ULN if liver metastases are present
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Albumin > 2.5 g/dL
  • Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to registration. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: breast milk cannot be stored for future use while the mother is being treated on study
  • Females of childbearing potential and males must be willing to abstain from heterosexual activity (abstinence) or use effective methods of contraception as described in Section 5.5 from the time of informed consent until 120 days after treatment discontinuation. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
  • Willingness to return to the enrolling institution for follow up
  • Willingness to provide tissue and blood samples for correlative research purposes


Exclusion Criteria:

  • Prior radiation to an area of the body which, if included in the current radiation field, poses an unacceptably high risk of toxicity in the opinion of the investigator. NOTE: A prior field that overlaps with the current field, by itself, does not exclude the patient.
  • Any of the following
    • Melanoma. NOTE: Positive tumor staining for S-100 or HMB45 alone does not exclude patients.
    • If immunostains are performed, and any of the below tests are positive:
      • Hematologic CD45+ (others such as CD2, CD20, CD30, CD43 also suggest hematologic origin)
      • Lung or thyroid origin (Thyroid Transcription Factor [TTF-1]). NOTE: Patients with biopsy proven TTF-1 positive tumor who do not have clinical evidence for either lung or thyroid cancer (e.g. a dominant lung mass) are still eligible.
  • Progressed on 4 or more lines of prior chemotherapy for this cancer. NOTE: Bisphosphonates and neoadjuvant/adjuvant anticancer therapies (including locally directed therapies) do not count as a line of therapy with regard to this exclusion criteria.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. NOTE: Inhaled steroids or steroid injections for joint disease are allowed.
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  • Prior severe allergic reactions to a monoclonal antibody or hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Other active malignancy which requires current treatment and which in the opinion of the site investigator is likely to interfere with evaluation of disease assessment. NOTE: Continuation of hormonal therapies is allowed.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Major surgery ≤ 4 weeks from registration. NOTE: Diagnostic laparoscopy (without other intervention) and/or biopsies (needle aspirate, core biopsy, open biopsy, etc…) are not considered major surgery
  • Uncontrolled intercurrent illness which in the opinion of the investigator poses unacceptably high risk when combined with study treatment, including but not limited to the following:
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Severely impaired lung function
    • Known history of active TB (Bacillus Tuberculosis)
    • Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (NOTE: Optimal glycemic control should be achieved before starting trial therapy.)
    • Significant underlying liver disease such as cirrhosis or severe hepatic impairment
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • For patients in whom planned RT fields will include the heart, any of the following heart conditions, if in the opinion of the investigator they pose unacceptably high risk when combined with study treatment:
    • Prior symptomatic congestive heart failure
    • Documented myocardial infarction ≤6 months prior to registration (pretreatment ECG evidence of infarct only will not exclude patients)
    • Prior significant ventricular arrhythmia requiring medication
    • Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay ≤ 6 months prior to registration
    • Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease ≤12 months prior to registration

NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease. These conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias. It is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo.

  • For patients in whom planned RT fields during the study will include the chest, any of the following, if in the opinion of the site investigator they pose unacceptably high risk when combined with study treatment:
    • Prior fistula within thorax, including bronchoalveolar or esophageal.
    • Respiratory condition that required oxygen supplementation ≤ 3 months prior to registration
    • Clinically significant pulmonary hypertension ≤ 12 months prior to registration
    • Pneumonia requiring treatment ≤ 1 month prior to registration
    • Pulmonary embolism requiring treatment ≤ 6 months prior to registration
    • Pleural effusion requiring drainage ≤ 12 months prior to registration
  • Has known history of or any evidence of active, non-infectious pneumonitis
  • Currently uncontrolled hyper/hypothyroidism or hyper/hypocortism if in the opinion of the investigator they pose unacceptably high risk when combined with study treatment
  • Received live vaccine ≤ 30 days prior to registration. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Biologic/Vaccine, Radiation, Administration of antineoplastic agent, Drug therapy, Radiation therapy procedure or service
Cancer, Cancer of unknown origin
Malignant tumor of unknown origin, Medical Oncology, Radiation therapy, pembrolizumab
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Mayo Clinic — Rochester, MN

MC1774, Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients with Newly Diagnosed Glioblastoma

Study to Determine the Impact of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (a chemical tracer that highlights certain cells during imaging) During Planning for Proton Beam Radiation Therapy.

Nadia Laack
All
65 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100153-P01-RST
17-007458
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Inclusion Criteria:

  • Age ≥ 65 years.
  • Histologically confirmed newly diagnosed Grade IV malignant glioma.
  • Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester.
  • Willing to sign release of information for any radiation and/or follow-up records.
  • Provide informed written consent.
  • Patients with eGFR ≥ 60 mg/min/1.72m^2.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • ECOG performance status 0, 1, 2.


Exclusion Criteria:

  • Patients diagnosed with Grades I-III glioma.
  • Currently on Avastin at time of treatment.
  • Unable to undergo MRI scans with contrast (e.g., cardiac pacemaker, defibrillator, kidney failure).
  • Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson’s Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists).
    • NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the On-Study form.
  • Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.
    • NOTE: All women enrolled in this study will be age 65 or over, and at the determination of the PI, will not be of childbearing potential.  If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care.

 

 

Radiation, MRI of brain and brain stem, Positron emission tomography, Proton therapy
Brain tumor, Cancer, Glioma
Cancer treatment, MRI, Malignant glioma of brain, Medical Oncology, Nervous system, Positron emission tomography scan, Proton therapy
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Mayo Clinic Rochester, MN — Rochester, MN

MC1733, Phase I Trial of intratumoral administration of a measles virus derivative expressing the Helicobacter pylori neutrophil-activating protein (NAP) (MV-s-NAP) in patients with metastatic breast cancer

MC1733, Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter pylori Neutrophil-activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer

Siddhartha Yadav
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100184-P01-RST
17-008299
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Inclusion Criteria:


- Pathologically confirmed invasive breast adenocarcinoma with documented estrogen
receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2
(HER2) status and radiographic evidence of distant metastatic disease.

- Radiographic evidence of distant metastatic disease (using 7th edition American Joint
Committee on Cancer [AJCC] criteria) with two discrete sites of measurable disease

- No available standard therapy that is considered curative.

- NOTE: Patients with ER/PR positive, HER2 negative breast cancer must have
progressed through at least one prior cytotoxic regimen for advanced disease and
no longer be candidates for standard endocrine therapy (including combination
therapy that includes palbociclib or everolimus). Patients with HER2 positive
breast cancer irrespective of ER/PR status must have received or no longer be
candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab,
trastuzumab, emtansine, and lapatinib). Patients with ER/PR/HER2 negative breast
cancer must have progressed through at least one prior cytotoxic regimen for
advanced disease

- At least one site of recurrent/metastatic disease that measures > 1 cm in greatest
dimension (> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral
administration of MV-s-NAP as determined by an interventional radiologist.

- NOTE: In Phase I of the trial (single injection), only one lesion will be
injected. In Phase II of the trial (3, every 3 weeks [Q3weekly] injections), the
same lesion will be injected unless the interventional radiologist determines
that lesion is not amenable to reinjection, in which case another lesion (if
present and measuring > 1 cm in greatest dimension [> 2 cm for lung lesions])
will be injected

- Absolute neutrophil count (ANC) >= 1500/uL (=< 7 days prior to registration)

- Platelets (PLT >= 100,000/uL) (=< 7 days prior to registration)

- Total bilirubin =< institutional upper limit of normal (=< 7 days prior to
registration)

- Aspartate aminotransferase (AST) =< 2 x upper limit of normal (ULN) (=< 7 days prior
to registration)

- Creatinine =< 1.5 x ULN (=< 7 days prior to registration)

- Hemoglobin >= 9.0 g/dL (=< 7 days prior to registration)

- Negative pregnancy test done =< 7 days prior to registration (for women of
childbearing potential only)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Ability to provide informed written consent

- Willingness to return to the Mayo Clinic enrolling institution for follow-up

- Willingness to provide biologic samples for correlative research purposes

- Life expectancy >= 12 weeks

- Concomitant administration of a bone modifying agent (e.g., zoledronic acid or
denosumab) for the prevention or management of skeletal related events in patients
with bone metastases and documentation of tolerability with prior exposures


Exclusion Criteria:


- Known standard therapy for the patient's disease that is potentially curative or
definitely capable of extending life expectancy

- Clinical or radiographic suspicion of impending visceral crisis due to invasion or
compression by tumor

- Active infection =< 5 days prior to registration

- History of tuberculosis or history of tuberculin skin test positivity

- History of other malignancy =< 5 years except for non-melanoma skin cancer or
carcinoma in situ of the cervix

- Any of the following prior therapies:

- Chemotherapy =< 3 weeks prior to registration

- Immunotherapy =< 4 weeks prior to registration

- HER2 directed therapy =< 3 weeks prior to registration

- Targeted therapy =< 2 weeks prior to registration (e.g., CDK4/6 inhibitors,
everolimus)

- Investigational agent =< 4 weeks prior to registration

- Any viral or gene therapy prior to registration

- Failure to fully recover from acute, reversible effects of prior systemic therapy
regardless of interval since last treatment

- New York Heart Association classification III or IV, known symptomatic coronary artery
disease, or symptoms of coronary artery disease on systems review, or known cardiac
arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])

- Untreated or progressive central nervous system (CNS) metastases

- NOTE: Patients with a history of treated brain metastases (surgical resection,
whole brain radiation, and/or stereotactic radiosurgery) are eligible only if
they are asymptomatic and have stable MRI scans for 3 consecutive months,
including < 28 days of study entry

- Standing requirement for blood product support

- Human immunodeficiency virus (HIV) positive test result or history of other
immunodeficiency

- History of organ transplantation

- History of chronic hepatitis B or C

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy
considered investigational (utilized for a non-Food and Drug Administration
[FDA]-approved indication and in the context of a research investigation)

- Any concurrent medications that the principal investigator determines could interfere
with the trial

- Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled
steroids

- Exposure to household contacts =< 15 months old or household contact with known
immunodeficiency

- Allergy to measles vaccine or history of severe reaction to prior measles vaccination

- History of receiving the measles vaccination with the "killed vaccine" between
1963-1967 without subsequent re-immunization (2 doses) with the active, live
vaccination."

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/7/22. Questions regarding updates should be directed to the study team contact.

Drug
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EAF151, Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

DSC-MRI in Measuring Relative Cerebral Blood Volume for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

Timothy Kaufmann
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100191-P01-RST
17-006593
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Inclusion Criteria:

  • Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
    • Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation)
  • Karnofsky performance status >= 70
  • Women must not be pregnant or breast-feeding
  • Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient?s initial recurrence
  • Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells)
  • Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2-weighted DSC-MRI images; if the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm ?measurable enhancement? threshold specified elsewhere, the patient is ineligible
  • Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir) on MRI within 14 days of registration, >= 42 days since completion of radiation/temozolomide therapy, and >= 28 days since surgical resection or cytotoxic chemotherapy; measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction
  • Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
    • Ability to withstand 22 gauge intravenous (IV) placement
    • No history of untreatable claustrophobia
    • No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies
    • No contraindication to intravenous contrast administration
      • Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents
    • No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
    • Weight compatible with limits imposed by the MRI scanner table
  • Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab (bevacizumab infusion on days 1 and 15 of a 28-day treatment cycle); patient can be treated with bevacizumab alone or in combination with other chemotherapies
Procedure/Surgery, Administration of antineoplastic agent, Blood volume estimation, Drug therapy, MRI of brain with contrast
Brain tumor, Cancer, Glioblastoma, Glioblastoma multiforme, Glioma, Recurrent cancer
Bevacizumab, Cancer treatment, Chemotherapy, Glioblastoma multiforme of brain, MRI, Medical Oncology, Nervous system, Recurrent malignant neoplastic disease, Targeted drug therapy, bevacizumab
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Mayo Clinic — Rochester, MN

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC) (ICONIC)

A Study to Test the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Lance Pagliaro
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100201-P01-RST
19-005143
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Eligibility Criteria: 

  • Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:
    • One measurable site of disease as per RECIST v1.1;
    • One bone lesion on bone scan (tec99 or NaF PET/CT, CT or MRI) for the bone-only cohort;
  • Histologically confirmed diagnosis of one of the following metastatic cohorts:
  • Small cell/ neuroendocrine carcinoma of the bladder - All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded;
  • Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma - must be pure (per WHO definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma;
  • Squamous cell carcinoma of the bladder
    must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma);
  • Plasmacytoid urothelial carcinoma - Tumor should show predominantly > or equal ~50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well).
  • Any penile cancer;
  • Sarcomatoid renal cell carcinoma - Tumor should be predominantly sarcomatoid ~50% (including rhabdoid differentiation) is also unclassified RCCs: all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed;
  • Sarcomatoid urothelial carcinoma - Tumor should show predominantly ~ 50% sarcomatoid differentiation;
  • Renal medullary carcinoma - Per WHO definition, ideally confirmed with immunostains;
  • Renal Collecting Duct Carcinoma
    Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma);
  • Bone only urothelial carcinoma or other non-prostate GU tumor;
  • Urethra carcinoma- May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder;
  • Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to: micropapillary (Tumor should show predominantly > or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly > or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC.Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial.
  • H&E slides from diagnostic tumor tissue for retrospective central pathology review.
  • Patients may have received up to 2 systemic anti-cancer treatments or be treatment naïve. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin- eligible).
  • Age ≥ 18 years.
  • Patients must be able to swallow oral formulation of the tablets.
  • Karnofsky performance status ≥ 80%.
  • Required Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥1,000/mcL;
    • Platelet Count ≥ 75,000/mcL;
    • Total Bilirubin ≤1.5 × ULN. For subjects with known Gilbert’s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin ≤ 3.0 mg/dL AST/ALT ≤3.0 × institutional upper limit of normal (ULN) (or ≤5 x ULN for patients with liver metastases or Gilbert’s disease);
    • Creatinine ≤ 1.5 x upper limit of normal (ULN); OR
    • Creatinine clearance ≥ 40 mL/min/1.73 m2 (calculated using the CKD-EPI equation or Cockroft-Gault formula) for patients with creatinine levels above institutional normal hemoglobin ≥9 g/dL (transfusion of PRBCs allowed) serum albumin ≥3.2g/dL lipase and amylase ≤2.0 × ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis.
  • Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed.
  • Prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA- 4/CTLA-4 inhibitors is allowed, either in the perioperative or in the metastatic setting. However, patients that have received both prior MET or VEGF and prior PD-1/PD- L1/CTLA-4 (sequentially or in combination) are not allowed.
  • HIV-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART) and no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable.
  • Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment.
  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (eg thyrodidits managed with PTU or methamizole) including physiologic oral corticosteroids are eligible.
  • Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and GI obstruction, within 12 months are not eligible.
  • Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to registration.
  • Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea ≥12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.
  • Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents.
  • The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment.
  • The patient has received no radiation therapy:
    • To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy;
    • To brain metastasis within 3 weeks for WBXRT, and 2 weeks for SBRT before the first dose of study treatment;
    • To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy;
    • To any other site(s) within 2 weeks before the first dose of study treatment.
  • The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment.
  • The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment.
  • The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving Gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate.
  • The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment.
  • The patient must have recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant AEs defined as lab elevation with no associated symptoms or sequelae.
  • The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.
  • No concomitant treatment with warfarin. Aspirin (up to 325 mg/day), thrombin or factor Xa inhibitors, low-dose warfarin (≤1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted.
  • No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John’s Wort) or strong CYP3A4 inhibitors.
  • Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians’ Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • The patient has not experienced any of the following:
    • Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment;
    • Hemoptysis of ≥ 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment;
    • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.
  • The patient has no tumor invading any major blood vessels.
  • The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible.
  • The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions.  Cardiovascular disorders including:
    • Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening;
    • Concurrent uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
    • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before randomization.
    • Note: if initial QTcF is found to be > 500 ms, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤500 ms, the subject meets eligibility in this regard.
    • Any history of congenital long QT syndrome.
  • Any of the following within 6 months before registration of study treatment:
    • unstable angina pectoris;
    • clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible);
    • stroke (including TIA, or other ischemic event)
    • myocardial infarction
    • cardiomyopathy.
  • No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
    • Any of the following that have not resolved within 28 days before the first dose of study treatment:
    • Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome;
    • Active peptic ulcer disease;
    • None of the following within 2 years before the first dose of study treatment:
    • abdominal fistula or genitourinary fistula
    • gastrointestinal perforation
    • bowel obstruction or gastric outlet obstruction
    • intra-abdominal abscess.
      • Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment.
  • Disorders associated with a high risk of fistula formation including PEG tube placement are not eligible.
  • No other clinically significant disorders such as:
    • severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment
    • serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
    • history of organ or allogeneic stem cell transplant
    • concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated TSH, thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)
    • No history of major surgery as follows:
    • Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post- surgery.
    • Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement.
  • Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery.
  • No history of severe hypersensitivity reaction to any monoclonal antibody.
  • No evidence of active malignancy, requiring systemic treatment within 2 years of registration.
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study.
  • No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent RNA PCR must be negative.
  • No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease.

Please Note: While patients may meet eligibility criteria, treating physicians should use best judgement to assess if the patient is a good candidate for this therapy with three drug combination regimen.

 

 

 

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Bladder cancer, Cancer, Germ cell tumor, Kidney cancer, Neuroendocrine carcinoma, Prostate cancer, Testicular cancer, Neuroendocrine tumor
Adenocarcinoma of bladder, Biological therapy for cancer, Cabozantinib, Cancer treatment, Chemotherapy, Chromophobe renal cell carcinoma, Ipilimumab, Large cell neuroendocrine carcinoma, Leydig cell neoplasm of testis, Lymphoepithelial carcinoma, MDX-1106, Malignant tumor of penis, Malignant tumor of prostate, Malignant tumor of urinary bladder, Medical Oncology, Metastatic penile cancer, Metastatic renal cell carcinoma, Papillary renal cell carcinoma, Renal cell carcinoma, Renal cell carcinoma, sarcomatoid, Renal medullary carcinoma, Reproductive system, Secondary malignant neoplastic disease, Sertoli cell tumor of testis, Small cell neuroendocrine carcinoma of bladder, Squamous cell carcinoma of bladder, Targeted drug therapy, Transitional cell carcinoma, micropapillary, Transitional cell carcinoma, spindle cell, Urinary system, cabozantinib, ipilimumab, nivolumab, Micropapillary urothelial carcinoma
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Mayo Clinic — Rochester, MN