A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)
Study Details
Study Description
Brief Summary
This phase II trial studies how well axitinib and nivolumab work in treating patients with TFE/translocation renal cell carcinoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating patients with TFE/translocation renal cell carcinoma compared to standard treatment, including surgery, chemotherapy, or immunotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- To establish the clinical activity, assessed primarily by progression-free survival, of nivolumab therapy with or without axitinib for advanced transcription factor E3/translocation morphology renal cell carcinoma (TFE/tRCC).
SECONDARY OBJECTIVE:
- To further define the toxicities of the study arms in the treatment of translocation morphology RCC across all ages.
EXPLORATORY OBJECTIVES:
-
To characterize tRCC clinical behavior across all age groups. II. To evaluate type of antitumor immune response and stability of T cell activation before and after treatment with immunotherapy or antiangiogenic therapy.
-
To develop a tumor bank of tRCC tumor samples treated on study for further biological investigations.
-
To characterize the pharmacokinetics of axitinib when given in combination with nivolumab in pediatric patients with tRCC.
OUTLINE: Patients are now randomized to 1 of 2 arms - Arm A or Arm C.
ARM A: Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)
ARM C: Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and every 6 months for 2 years. Follow-up at year 5 and beyond is at the discretion of the treating physician.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A (axitinib, nivolumab) Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. |
Drug: Axitinib
Given PO
Other Names:
Biological: Nivolumab
Given IV
Other Names:
|
| Experimental: Arm B (axitinib) Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C) |
Drug: Axitinib
Given PO
Other Names:
|
| Experimental: Arm C (nivolumab) Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. |
Biological: Nivolumab
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression free survival [From randomization to the earliest of disease progression (according to Response Evaluation Criteria in Solid Tumors adapted for immunotherapy) or death due to any cause, assessed up to 4 years]
Secondary Outcome Measures
- Overall survival [From randomization to death due to any cause, assessed up to 4 years]
A stratified, one-sided log-rank test (using the stratification factors at randomization, age and prior therapy) will be performed to compare treatment arms with alpha = 0.05. Cox proportional hazards models will also be fit to evaluate the final hazard ratio between the treatment arms, with exploratory modeling taking into account the potential influence of other factors (e.g., baseline disease burden, upfront versus delayed nephrectomy). From these models, the hazard ratio for treatment assignment will be reported with a 90% confidence interval (to align with the overall alpha level of the primary log-rank test).
- Overall response rate (ORR) [Up to 4 years]
Will be defined as the rate of complete or partial responses (assessed by imaging) among patients who initiated protocol therapy and completed at least one subsequent imaging assessment. A logistic regression model for overall response, stratified by the stratification factors used at randomization (age and prior therapy) will be fit, including treatment arm as a key covariate. From this model, the odds ratio for treatment arm will be reported with a 90% confidence interval. The ORR observed within each treatment arm will also be reported.
- Incidence of adverse events (AEs) [Within 30 days of treatment discontinuation]
All grade 3 non-hematologic toxicities and all grade 4-5 or higher adverse events occurring during protocol therapy or within 30 days of treatment discontinuation will be analyzed. The rates of these events will be reported separately by treatment arm with 95% exact confidence intervals, both by individual AE and class of AE (e.g., hematologic). Given that some AEs may be rare, Fisher Exact tests will be used to test for statistical significance among any apparent differences by treatment arm.
Other Outcome Measures
- Translocation morphology renal cell carcinoma clinical behavior [Up to 4 years]
Will list and summarize the frequency of site(s) of disease at presentation (including extent of lymph node involvement), site(s) of relapse, surgical practices on protocol therapy, and radiotherapy practices on protocol therapy.
- Type of antitumor immune response and stability of T cell activation [Baseline up to 4 years]
Will summarize the levels of analytes and tumor expression before and after treatment and evaluate the changes due to treatment after logarithmic transformation using the paired t-test. Analytes include myeloid derived stem cells: CD45, CD11b, CD33, CD14, CD15, HLA-DR, viability, stain 1; regulatory T cells: viability, CD45, CE4, CD3, CD24, FoxP3; CD8 T cells (CD45, CD8, CD3); CD8 phenotype and activation and exhaustion (CD69, CD38, PD1, CD244, TIM3). Tumor expression of PDL-1, PD1, CD3, CD4 and CD8 will be assessed using TFE renal cell carcinoma samples from the study and scored for intensity (0-3).
- Pharmacokinetics (PK) of axitinib [Up to 4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be >= 12 months at enrollment
-
Patients must have a body surface area (BSA) >= 0.53 m^2
-
Histologically confirmed unresectable or metastatic translocation morphology renal cell carcinoma diagnosed using World Health Organization (WHO)-defined criteria. Patients may be newly diagnosed or have received prior cancer therapy
-
Patients must have had histologic verification of the malignancy
-
Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
-
Patients must have a tumor showing the appropriate morphologic appearance, and either confirmed TFE3 nuclear protein expression by immunohistochemistry with appropriate positive and negative controls performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, or evidence of TFE3 or TFEb translocation by either fluorescence in situ hybridization (FISH) or reverse transcriptase- polymerase chain reaction (RT-PCR) performed at a CLIA-certified laboratory. For TFE3 immunohistochemistry, any nuclear positivity in the presence of appropriate positive and negative controls should be considered as evidence of TFE3 immunohistochemical expression. NOTE: If the institution is unable to perform these studies, unstained slides may be submitted to Dr. Elizabeth Perlman, who will perform TFE3 analysis at no charge. The slide will be returned to the referring institution for local evaluation, to be included in their institutional report
-
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
-
Patients must have a life expectancy of >= 8 weeks
-
Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
-
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)
-
Immunotherapy: Must not have received within 4 weeks of entry onto this study
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Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent
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Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
-
Peripheral absolute neutrophil count (ANC) >= 1000/uL (performed within 7 days prior to enrollment)
-
Platelet count >= 75,000/uL (transfusion independent) (performed within 7 days prior to enrollment)
-
Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (performed within 7 days prior to enrollment)
-
Urine protein: =< 30 mg/dL in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hours (h) urine sample (performed within 7 days prior to enrollment)
-
For patients < 18 years of age: Serum creatinine =< 1.5 x upper limit of normal (ULN), or measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 for patient with creatinine levels > 1.5 x institutional ULN, or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):
-
1 to < 2 years - 0.6 mg/dL (male, female)
-
2 to < 6 years - 0.8 mg/dL (male, female)
-
6 to < 10 years - 1 mg/dL (male, female)
-
10 to < 13 years - 1.2 mg/dL (male, female)
-
13 to < 16 years - 1.5 mg/dL (male), 1.4 mg/dL (female)
-
= 16 years - 1.7 mg/dL (male), 1.4 mg/dL (female)
-
Creatinine clearance should be calculated per institutional standard
-
For patients >= 18 years of age: Serum creatinine =< 2 x ULN, or measured or calculated creatinine clearance or radioisotope GFR >= 40 mL/min/1.73 m^2 for patient with creatinine levels > 2 x institutional ULN (performed within 7 days prior to enrollment)
-
Creatinine clearance should be calculated per institutional standard
-
Serum total bilirubin =< 1.5 x ULN for age, or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 X ULN (performed within 7 days prior to enrollment)
-
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age (performed within 7 days prior to enrollment)
-
Albumin > 2.5 mg/dL (performed within 7 days prior to enrollment)
-
Shortening fraction of >= 27% by echocardiogram, or
-
Ejection fraction of >= 50% by radionuclide angiogram
-
No history of myocardial infarction, severe or unstable angina, or peripheral vascular disease
-
Corrected QT (QTc) =< 480 msec. Note: Patients with grade 1 prolonged QTc (450-480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications)
-
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN. However, if patient is receiving anticoagulant therapy, PT or partial thromboplastin time (PTT) should be within therapeutic range of intended use of anticoagulants
-
Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
-
A baseline blood pressure (BP) =< the 95th percentile for age, height, and gender for patients < 18 years old, or =< 150 mmHg (systolic) and =< 90 mmHg (diastolic) for patients >= 18 years old
-
Note: 2 serial blood pressures should be taken at least 1 hour apart and averaged to determine baseline BP
-
Patients are eligible if on stable doses (>= 7 days) of anti-hypertensive medications with a baseline BP meeting the criteria above
Exclusion Criteria:
-
Patients unable to swallow whole tablets
-
Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible
-
Prior Therapy
-
Patients who have received prior therapy with axitinib, nivolumab, or other PD1/PD-L1 targeted therapies
-
Patients who have received prior therapy with more than one anti VEGF based agent (antibody or tyrosine kinase inhibitor)
-
Patients with hypersensitivity to axitinib, nivolumab, or any of its excipients
-
Patients who previously received an allogeneic stem cell transplant (SCT) or solid organ transplant are not eligible
-
Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)
-
Patients who have received prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study enrollment or who have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment
-
Surgery: Patients who have had or who are planning to have the following invasive procedures are not eligible:
-
Major surgical procedure, laparoscopic procedure, open biopsy, core biopsy, fine needle aspirate, or significant traumatic injury within 7 days prior to enrollment. NOTE: External central lines must be placed at least 3 days prior to planned treatment initiation and subcutaneous ports must be placed at least 7 days prior to planned treatment initiation
-
Patients who are planning cytoreductive surgery within the first 12 weeks following therapy initiation
-
Patients who have a serious or non-healing wound or ulcer at the time of study enrollment are not eligible
-
Patients who have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment are not eligible
-
Patients who have received prior targeted small molecule therapy within 2 weeks of enrollment or have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks prior to enrollment. NOTE: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
-
Pre-existing conditions, which may include:
-
Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer
-
Patients with underlying immune deficiency, chronic infections including hepatitis, tuberculosis (TB), or autoimmune disease
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Human immunodeficiency virus (HIV)-infected patients with the exception of patients on an effective anti-retroviral therapy with an undetectable viral load within 6 months prior to enrollment
-
Patients with underlying hematologic issues including congenital bleeding diathesis, known previous gastrointestinal (GI) bleeding requiring intervention within the past 6 months, history of hemoptysis within 42 days prior to study enrollment, active pulmonary emboli, or deep vein thromboses (DVT) that are not stable on anticoagulation regimen
-
Patients must not have had significant vascular disease (i.e. Moya-Moya, aortic aneurysm requiring surgical repair)
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A known history of, or any evidence of active, non-infectious pneumonitis
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Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study enrollment 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 study enrollment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
-
Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
-
Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the investigator(s) to interfere or limit compliance with study requirements/treatment
-
Patients with 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
-
Treatments and/or medications the patient is receiving or has received that would make her/him ineligible, including:
-
Concomitant (or receipt of) treatment with medications that may affect the metabolism of nivolumab and/or axitinib within 7 days prior to planned first dose of protocol therapy
-
A live vaccine within 30 days of planned first dose of protocol therapy. NOTE: Inactivated flu vaccines are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
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Pregnancy and breast feeding
-
Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
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Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of study drug
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Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of study therapy
-
Male patients of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy. Prior history of vasectomy does not replace requirement for contraceptive use
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Regulatory requirements
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All patients and/or their parents or legal guardians must sign a written informed consent
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All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | CTCA at Western Regional Medical Center | Goodyear | Arizona | United States | 85338 |
| 3 | Cancer Center at Saint Joseph's | Phoenix | Arizona | United States | 85004 |
| 4 | CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas | United States | 71913 |
| 5 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202-3591 |
| 6 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
| 7 | Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | United States | 93420 |
| 8 | PCR Oncology | Arroyo Grande | California | United States | 93420 |
| 9 | Kaiser Permanente-Bellflower | Bellflower | California | United States | 90706 |
| 10 | Kaiser Permanente Downey Medical Center | Downey | California | United States | 90242 |
| 11 | Kaiser Permanente-Fontana | Fontana | California | United States | 92335 |
| 12 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 13 | Mattel Children's Hospital UCLA | Los Angeles | California | United States | 90095 |
| 14 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 15 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 16 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 17 | Kaiser Permanente-San Diego Mission | San Diego | California | United States | 92108 |
| 18 | Pacific Central Coast Health Center-San Luis Obispo | San Luis Obispo | California | United States | 93401 |
| 19 | Mission Hope Medical Oncology - Santa Maria | Santa Maria | California | United States | 93444 |
| 20 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 21 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 22 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
| 23 | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | United States | 80907 |
| 24 | Saint Francis Cancer Center | Colorado Springs | Colorado | United States | 80923 |
| 25 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 26 | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | United States | 80218 |
| 27 | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 28 | Mercy Medical Center | Durango | Colorado | United States | 81301 |
| 29 | Southwest Oncology PC | Durango | Colorado | United States | 81301 |
| 30 | Mountain Blue Cancer Care Center | Golden | Colorado | United States | 80401 |
| 31 | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | United States | 80228 |
| 32 | Saint Anthony Hospital | Lakewood | Colorado | United States | 80228 |
| 33 | Littleton Adventist Hospital | Littleton | Colorado | United States | 80122 |
| 34 | Longmont United Hospital | Longmont | Colorado | United States | 80501 |
| 35 | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado | United States | 80501 |
| 36 | Parker Adventist Hospital | Parker | Colorado | United States | 80138 |
| 37 | Rocky Mountain Cancer Centers-Parker | Parker | Colorado | United States | 80138 |
| 38 | Saint Mary Corwin Medical Center | Pueblo | Colorado | United States | 81004 |
| 39 | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado | United States | 81008 |
| 40 | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | United States | 80260 |
| 41 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 42 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 43 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 44 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 45 | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 46 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 47 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 48 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 49 | Nicklaus Children's Hospital | Miami | Florida | United States | 33155 |
| 50 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 51 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 52 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 53 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 54 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 55 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 56 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 57 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 58 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 59 | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | United States | 60045 |
| 60 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 61 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 62 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 63 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 64 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 65 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
| 66 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
| 67 | Alegent Health Mercy Hospital | Council Bluffs | Iowa | United States | 51503 |
| 68 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
| 69 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
| 70 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 71 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 72 | Mercy Medical Center-West Lakes | West Des Moines | Iowa | United States | 50266 |
| 73 | Flaget Memorial Hospital | Bardstown | Kentucky | United States | 40004 |
| 74 | Commonwealth Cancer Center-Corbin | Corbin | Kentucky | United States | 40701 |
| 75 | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky | United States | 40504 |
| 76 | Saint Joseph Hospital East | Lexington | Kentucky | United States | 40509 |
| 77 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 78 | Saint Joseph London | London | Kentucky | United States | 40741 |
| 79 | Jewish Hospital | Louisville | Kentucky | United States | 40202 |
| 80 | Saints Mary and Elizabeth Hospital | Louisville | Kentucky | United States | 40215 |
| 81 | UofL Health Medical Center Northeast | Louisville | Kentucky | United States | 40245 |
| 82 | Jewish Hospital Medical Center South | Shepherdsville | Kentucky | United States | 40165 |
| 83 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 84 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 85 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 86 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 87 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 88 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 89 | Huron Medical Center PC | Port Huron | Michigan | United States | 48060 |
| 90 | Lake Huron Medical Center | Port Huron | Michigan | United States | 48060 |
| 91 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 92 | Minnesota Oncology - Burnsville | Burnsville | Minnesota | United States | 55337 |
| 93 | Cambridge Medical Center | Cambridge | Minnesota | United States | 55008 |
| 94 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 95 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 96 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 97 | Fairview Clinics and Surgery Center Maple Grove | Maple Grove | Minnesota | United States | 55369 |
| 98 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 99 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 100 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 101 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 102 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 103 | Health Partners Inc | Minneapolis | Minnesota | United States | 55454 |
| 104 | Monticello Cancer Center | Monticello | Minnesota | United States | 55362 |
| 105 | New Ulm Medical Center | New Ulm | Minnesota | United States | 56073 |
| 106 | Fairview Northland Medical Center | Princeton | Minnesota | United States | 55371 |
| 107 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 108 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 109 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 110 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 111 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
| 112 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
| 113 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 114 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 115 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 116 | Fairview Lakes Medical Center | Wyoming | Minnesota | United States | 55092 |
| 117 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 118 | Children's Mercy Hospitals and Clinics | Kansas City | Missouri | United States | 64108 |
| 119 | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri | United States | 63104 |
| 120 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 121 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 122 | CHI Health Saint Francis | Grand Island | Nebraska | United States | 68803 |
| 123 | Heartland Hematology and Oncology | Kearney | Nebraska | United States | 68845 |
| 124 | CHI Health Good Samaritan | Kearney | Nebraska | United States | 68847 |
| 125 | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska | United States | 68510 |
| 126 | Alegent Health Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
| 127 | Hematology and Oncology Consultants PC | Omaha | Nebraska | United States | 68122 |
| 128 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 129 | Alegent Health Lakeside Hospital | Omaha | Nebraska | United States | 68130 |
| 130 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 131 | Midlands Community Hospital | Papillion | Nebraska | United States | 68046 |
| 132 | Carson Tahoe Regional Medical Center | Carson City | Nevada | United States | 89703 |
| 133 | Cancer and Blood Specialists-Henderson | Henderson | Nevada | United States | 89052 |
| 134 | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | United States | 89052 |
| 135 | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | United States | 89052 |
| 136 | Las Vegas Cancer Center-Henderson | Henderson | Nevada | United States | 89052 |
| 137 | OptumCare Cancer Care at Seven Hills | Henderson | Nevada | United States | 89052 |
| 138 | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | United States | 89074 |
| 139 | GenesisCare USA - Henderson | Henderson | Nevada | United States | 89074 |
| 140 | Las Vegas Urology - Green Valley | Henderson | Nevada | United States | 89074 |
| 141 | Urology Specialists of Nevada - Green Valley | Henderson | Nevada | United States | 89074 |
| 142 | Desert West Surgery | Las Vegas | Nevada | United States | 89102 |
| 143 | OptumCare Cancer Care at Charleston | Las Vegas | Nevada | United States | 89102 |
| 144 | University Medical Center of Southern Nevada | Las Vegas | Nevada | United States | 89102 |
| 145 | Hope Cancer Care of Nevada | Las Vegas | Nevada | United States | 89103 |
| 146 | Cancer and Blood Specialists-Shadow | Las Vegas | Nevada | United States | 89106 |
| 147 | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | United States | 89106 |
| 148 | Urology Specialists of Nevada - Central | Las Vegas | Nevada | United States | 89106 |
| 149 | GenesisCare USA - Las Vegas | Las Vegas | Nevada | United States | 89109 |
| 150 | HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada | United States | 89109 |
| 151 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
| 152 | HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | United States | 89113 |
| 153 | Las Vegas Urology - Sunset | Las Vegas | Nevada | United States | 89113 |
| 154 | Urology Specialists of Nevada - Southwest | Las Vegas | Nevada | United States | 89113 |
| 155 | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | United States | 89119 |
| 156 | Cancer Therapy and Integrative Medicine | Las Vegas | Nevada | United States | 89121 |
| 157 | Ann M Wierman MD LTD | Las Vegas | Nevada | United States | 89128 |
| 158 | Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada | United States | 89128 |
| 159 | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | United States | 89128 |
| 160 | GenesisCare USA - Vegas Tenaya | Las Vegas | Nevada | United States | 89128 |
| 161 | HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada | United States | 89128 |
| 162 | OptumCare Cancer Care at MountainView | Las Vegas | Nevada | United States | 89128 |
| 163 | Urology Specialists of Nevada - Northwest | Las Vegas | Nevada | United States | 89128 |
| 164 | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | United States | 89135 |
| 165 | Comprehensive Cancer Centers of Nevada - Town Center | Las Vegas | Nevada | United States | 89144 |
| 166 | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | United States | 89144 |
| 167 | Summerlin Hospital Medical Center | Las Vegas | Nevada | United States | 89144 |
| 168 | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | United States | 89148-2405 |
| 169 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
| 170 | GenesisCare USA - Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 171 | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 172 | HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada | United States | 89149 |
| 173 | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | United States | 89169 |
| 174 | University Cancer Center | Las Vegas | Nevada | United States | 89169 |
| 175 | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | United States | 89048 |
| 176 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 177 | Saint Mary's Regional Medical Center | Reno | Nevada | United States | 89503 |
| 178 | Radiation Oncology Associates | Reno | Nevada | United States | 89509 |
| 179 | Cancer Care Specialists - Reno | Reno | Nevada | United States | 89511 |
| 180 | Albany Medical Center | Albany | New York | United States | 12208 |
| 181 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 182 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 183 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 184 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 185 | Mission Hospital | Asheville | North Carolina | United States | 28801 |
| 186 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 187 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 188 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 189 | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 190 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 191 | Bethesda North Hospital | Cincinnati | Ohio | United States | 45242 |
| 192 | TriHealth Cancer Institute-Westside | Cincinnati | Ohio | United States | 45247 |
| 193 | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio | United States | 45255 |
| 194 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 195 | Rainbow Babies and Childrens Hospital | Cleveland | Ohio | United States | 44106 |
| 196 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 197 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 198 | Dayton Children's Hospital | Dayton | Ohio | United States | 45404 |
| 199 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
| 200 | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | United States | 43606 |
| 201 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 202 | Cancer Treatment Centers of America | Tulsa | Oklahoma | United States | 74133 |
| 203 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 204 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 205 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 206 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 207 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 208 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 209 | Prisma Health Cancer Institute - Laurens | Clinton | South Carolina | United States | 29325 |
| 210 | Prisma Health Cancer Institute - Easley | Easley | South Carolina | United States | 29640 |
| 211 | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | United States | 29605 |
| 212 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 213 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 214 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
| 215 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 216 | Memorial Hospital | Chattanooga | Tennessee | United States | 37404 |
| 217 | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee | United States | 37343 |
| 218 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 219 | Saint Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 220 | The Children's Hospital at TriStar Centennial | Nashville | Tennessee | United States | 37203 |
| 221 | Memorial GYN Plus | Ooltewah | Tennessee | United States | 37363 |
| 222 | Dell Children's Medical Center of Central Texas | Austin | Texas | United States | 78723 |
| 223 | Saint Joseph Regional Cancer Center | Bryan | Texas | United States | 77802 |
| 224 | El Paso Children's Hospital | El Paso | Texas | United States | 79905 |
| 225 | Cook Children's Medical Center | Fort Worth | Texas | United States | 76104 |
| 226 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 227 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 228 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 229 | University Hospital | San Antonio | Texas | United States | 78229 |
| 230 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 231 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 232 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 233 | Overlake Medical Center | Bellevue | Washington | United States | 98004 |
| 234 | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | United States | 98310 |
| 235 | Harrison Medical Center | Bremerton | Washington | United States | 98310 |
| 236 | Highline Medical Center-Main Campus | Burien | Washington | United States | 98166 |
| 237 | Saint Elizabeth Hospital | Enumclaw | Washington | United States | 98022 |
| 238 | Saint Francis Hospital | Federal Way | Washington | United States | 98003 |
| 239 | Saint Clare Hospital | Lakewood | Washington | United States | 98499 |
| 240 | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | United States | 98370 |
| 241 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 242 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 243 | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington | United States | 98405 |
| 244 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
| 245 | Northwest Medical Specialties PLLC | Tacoma | Washington | United States | 98405 |
| 246 | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 247 | West Virginia University Charleston Division | Charleston | West Virginia | United States | 25304 |
| 248 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 249 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 250 | Holy Family Memorial Hospital | Manitowoc | Wisconsin | United States | 54221 |
| 251 | Saint Vincent Hospital Cancer Center at Marinette | Marinette | Wisconsin | United States | 54143 |
| 252 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 253 | Cancer Center of Western Wisconsin | New Richmond | Wisconsin | United States | 54017 |
| 254 | Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls | Wisconsin | United States | 54154 |
| 255 | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin | United States | 53081 |
| 256 | Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235-1495 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: James I Geller, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2018-01489
- NCI-2018-01489
- AREN1721
- AREN1721
- U10CA180886