Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors
Study Details
Study Description
Brief Summary
This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.
Detailed Description
PRIMARY OBJECTIVES:
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To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults with Ewing sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, and Wilms tumor.
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To estimate whether XL184 therapy either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to a historical Childrens Oncology Group (COG) experience or produces an objective response rate.
SECONDARY OBJECTIVES:
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To further define XL184 related toxicities in pediatric, adolescent and young adult patients.
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To further define XL184 pharmacokinetics in the pediatric and adolescent patients.
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To estimate 1-year time to progression, progression free survival (PFS) and overall survival for each stratum, and if feasible to compare to historical controls.
EXPLORATORY OBJECTIVES:
- To assess the effect of XL184 on patients' immune cell subsets. II. To obtain tumor tissue (snap frozen, formalin-fixed and paraffin-embedded [FFPE] blocks, or unstained slides) from diagnosis, recurrence, or both, for possible future studies.
OUTLINE:
Patients receive cabozantinib-s-malate orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 6 months for 1 year and then annually for up to 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (cabozantinib s-malate) Patients receive cabozantinib-s-malate orally (PO) on a continuous dosing schedule using a dosing nomogram on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: Cabozantinib
Given PO
Drug: Cabozantinib S-malate
Given PO
Note: Capsule formulation (Cometriq) not used in this trial.
Other Names:
Other: Pharmacological Study
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Objective response (Non-Osteosarcoma Strata) [Up to the first 6 cycles of therapy]
Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed accounting for the two-stage design.
- Objective response (Osteosarcoma Stratum) [Up to the first 6 cycles of therapy.]
Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design
Secondary Outcome Measures
- Incidence of adverse events [Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy)]
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy
- Pharmacokinetics (PK) parameters of cabozantinib s-malate: Cmax [Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1]
Day 1 PK peak concentration will be summarized by the mean and the standard deviation.
- Pharmacokinetics (PK) parameters of cabozantinib s-malate: Tmax [Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1]
Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation.
- Pharmacokinetics (PK) parameters of cabozantinib s-malate: AUC [Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1]
Day 1 PK area under the curve will be summarized by the mean and the standard deviation.
- Pharmacokinetics (PK) parameters of cabozantinib s-malate: Accumulation [Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22]
PK accumulation will be summarized by the mean and the standard deviation.
- Pharmacokinetics (PK) parameters of cabozantinib s-malate: Half-life [Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22]
PK half-life will be summarized by the mean and the standard deviation.
- Time to Progression (TTP) [Up to 1 year]
The 1-year Time to Progression will be estimated using Kaplan-Meier methodology.
- Progression free survival (PFS) [Up to 1 year]
The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology.
- Overall Survival (OS) [Up to 1 year]
The 1-year Overall Survival will be estimated using Kaplan-Meier methodology.
Other Outcome Measures
- Change in immune biomarkers [Baseline, day 1 (prior to dose) of cycles 2 and 3]
The association between the host immune system and response to cabozantinib-s-malate will be assessed in an exploratory manner. each biomarker will be correlated with the clinical outcomes of objective response and progression free survival.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) =< 30 years for all other diagnoses
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Patients must have a body surface area >= 0.35 m^2
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Patients must have recurrent or refractory disease, or newly diagnosed disease with no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse:
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Ewing sarcoma
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Rhabdomyosarcoma (RMS)
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Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS])
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Osteosarcoma
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Wilms tumor
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Rare tumors
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Medullary thyroid carcinoma (MTC)
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Renal cell carcinoma (RCC)
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Hepatocellular carcinoma (HCC)
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Hepatoblastoma
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Adrenal coertex carcinoma
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Pediatric solid tumors (including central nervous system [CNS] tumors) with known molecular alterations in the targets of XL184 (i.e., MET amplification, overexpression, activating mutation, MET translocation, MET exon skipping mutations, activating RET mutations, RET rearrangement, overexpression or activation of AXL); documentation of the alteration from a Clinical Laboratory Improvement Act (CLIA) certified laboratory will be required
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Note: Documentation of any known tumor molecular alterations and RET mutation status for patients with MTC (germline) must be uploaded via the RAVE system
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Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
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Note: The following do NOT qualify as measurable disease:
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Malignant fluid collections (e.g., ascites, pleural effusions)
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Bone marrow infiltration
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Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans)
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Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
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Previously radiated lesions that have not demonstrated clear progression post radiation
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Leptomeningeal lesions that do not meet the measurement parameters noted above
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Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
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Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
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Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
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At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim
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Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
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Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
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= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of M-Iodobenzylguanidine (MIBG); >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total-body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given
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Subjects should not have any clinically relevant ongoing complications from prior radiation therapy (i.e., radiation esophagitis or other inflammation of the viscera)
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No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
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Not previously received XL184 or another MET/HGF inhibitor (tivantinib or crizotinib); there are no limits on number of prior therapeutic regimens; patients who have been treated with prior VEGF pathway, or RET inhibitors (except XL184) may be eligible
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Peripheral absolute neutrophil count (ANC) >= 1000/uL for patients with solid tumors without bone marrow involvement
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Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) for patients with solid tumors without bone marrow involvement
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Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) for patients with solid tumors without bone marrow involvement
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Peripheral absolute neutrophil count (ANC) >= 750/uL for patients with solid tumors and known bone marrow metastatic disease
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Platelet count >= 50,000/uL for patients with solid tumors and known bone marrow metastatic disease
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Hemoglobin >= 8.0 g/dL for patients with solid tumors and known bone marrow metastatic disease
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Transfusions are permitted to meet both the platelet and hemoglobin criteria for patients with known bone marrow metastatic disease; patients must not be known to be refractory to red blood cell or platelet transfusions
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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:
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2 to < 6 years of age
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Male and female: 0.8 (maximum serum creatinine [mg/dL])
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6 to < 10 years of age
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Male and female: 1 (maximum serum creatinine [mg/dL])
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10 to < 13 years of age
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Male and female: 1.2 (maximum serum creatinine [mg/dL])
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13 to < 16 years of age
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Male 1.5 (maximum serum creatinine [mg/dL])
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Female: 1.4 (maximum serum creatinine [mg/dL])
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= 16 years of age
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Male: 1.7 (maximum serum creatinine [mg/dL])
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Female: 1.4 (maximum serum creatinine [mg/dL])
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Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample
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Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
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Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3 x ULN) (for the purpose of this study, the ULN for SGPT is 45 U/L)
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Serum albumin >= 2.8 g/dL
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No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
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No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment
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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)
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Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled
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CNS toxicity =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
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A blood pressure (BP) =< the 95th percentile for age, height, and gender for pediatric patients < 18 years old and =< 140/90 mmHg for patients >= 18 years old; patients should not be receiving medication for treatment of hypertension (except patients with Wilms tumor and RCC who may be eligible if on stable doses of no more than one anti-hypertensive medication with a baseline BP =< ULN for pediatric patients and =< 140/90 for adult patients); please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP
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International normalized ratio (INR) =< 1.5
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Serum amylase =< 1.5 x ULN
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Serum lipase =< 1.5 x ULN
Exclusion Criteria:
-
Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control- a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective method of birth control-during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control
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Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)
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Patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
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Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)
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Patients who are currently receiving another investigational drug are not eligible
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Patients who are currently receiving other anti-cancer agents are not eligible
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Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
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Patients must not be receiving any of the following potent CYP3A4 inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort
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Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited
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Note: Low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted; anticoagulation with therapeutic doses of LMWH is allowed in subjects without radiographic evidence of brain metastasis, who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen
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Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
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Patients who are receiving drugs that prolong QTc are not eligible
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Patients who are unable to swallow intact tablets are not eligible
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Patients who have an uncontrolled infection are not eligible
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Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
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Patients with active bleeding are not eligible; specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment; patients with evidence of an acute intracranial or intratumoral hemorrhage on CT or MRI are not eligible (patients with evidence of resolving hemorrhage will be eligible); in patients with CNS tumors, an MRI with ECHO gradient sequences would be required to exclude presence of petechial hemorrhages
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Patients who have had or are planning to have the following invasive procedures are not eligible:
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Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment
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Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port
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Core biopsy within 7 days prior to enrollment
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Fine needle aspirate within 7 days prior to enrollment
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Surgical or other wounds must be adequately healed prior to enrollment
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NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
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Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible
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Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 3 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202-3591 |
| 4 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
| 5 | Kaiser Permanente-Bellflower | Bellflower | California | United States | 90706 |
| 6 | Kaiser Permanente Downey Medical Center | Downey | California | United States | 90242 |
| 7 | Kaiser Permanente-Fontana | Fontana | California | United States | 92335 |
| 8 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 9 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 10 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 11 | Valley Children's Hospital | Madera | California | United States | 93636 |
| 12 | UCSF Benioff Children's Hospital Oakland | Oakland | California | United States | 94609 |
| 13 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 14 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 15 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 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 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
| 19 | UCSF Medical Center-Mission Bay | San Francisco | California | United States | 94158 |
| 20 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 21 | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 22 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 23 | Yale University | New Haven | Connecticut | United States | 06520 |
| 24 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 25 | Kaiser Permanente-Capitol Hill Medical Center | Washington | District of Columbia | United States | 20002 |
| 26 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 27 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 28 | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | United States | 33908 |
| 29 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 30 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 31 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 32 | Nicklaus Children's Hospital | Miami | Florida | United States | 33155 |
| 33 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 34 | Arnold Palmer Hospital for Children | Orlando | Florida | United States | 32806 |
| 35 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 36 | Nemours Children's Clinic - Pensacola | Pensacola | Florida | United States | 32504 |
| 37 | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 38 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 39 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 40 | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii | United States | 96819 |
| 41 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 42 | Saint Luke's Cancer Institute - Boise | Boise | Idaho | United States | 83712 |
| 43 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60611 |
| 44 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 45 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 46 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 47 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 48 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 49 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 50 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 51 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 52 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 53 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 54 | Blank Children's Hospital | Des Moines | Iowa | United States | 50309 |
| 55 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 56 | Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
| 57 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 58 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 59 | Norton Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 60 | Children's Hospital New Orleans | New Orleans | Louisiana | United States | 70118 |
| 61 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 62 | Lafayette Family Cancer Center-EMMC | Brewer | Maine | United States | 04412 |
| 63 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 64 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 65 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
| 66 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 67 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 68 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 69 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 70 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 71 | Huron Medical Center PC | Port Huron | Michigan | United States | 48060 |
| 72 | Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 73 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 74 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 75 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 76 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 77 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 78 | Children's Mercy Hospitals and Clinics | Kansas City | Missouri | United States | 64108 |
| 79 | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri | United States | 63104 |
| 80 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
| 81 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 82 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 83 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 84 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 85 | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | United States | 68114 |
| 86 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 87 | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada | United States | 89052 |
| 88 | Sunrise Hospital and Medical Center | Las Vegas | Nevada | United States | 89109 |
| 89 | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | United States | 89135 |
| 90 | Summerlin Hospital Medical Center | Las Vegas | Nevada | United States | 89144 |
| 91 | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada | United States | 89048 |
| 92 | Radiation Oncology Associates | Reno | Nevada | United States | 89509 |
| 93 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 94 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 95 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 96 | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
| 97 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 98 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
| 99 | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | United States | 11040 |
| 100 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 101 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 102 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 103 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 104 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 105 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 106 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 107 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 108 | Wayne Memorial Hospital | Goldsboro | North Carolina | United States | 27534 |
| 109 | East Carolina University | Greenville | North Carolina | United States | 27834 |
| 110 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 111 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 112 | Rainbow Babies and Childrens Hospital | Cleveland | Ohio | United States | 44106 |
| 113 | MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 114 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 115 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 116 | Dayton Children's Hospital | Dayton | Ohio | United States | 45404 |
| 117 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
| 118 | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | United States | 43606 |
| 119 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 120 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 121 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 122 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 123 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 124 | Saint Francis Hospital | Greenville | South Carolina | United States | 29601 |
| 125 | BI-LO Charities Children's Cancer Center | Greenville | South Carolina | United States | 29605 |
| 126 | Saint Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 127 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 128 | Saint Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 129 | The Children's Hospital at TriStar Centennial | Nashville | Tennessee | United States | 37203 |
| 130 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 131 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 132 | El Paso Children's Hospital | El Paso | Texas | United States | 79905 |
| 133 | Texas Tech University Health Sciences Center-El Paso | El Paso | Texas | United States | 79905 |
| 134 | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | United States | 77030 |
| 135 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 136 | University of Vermont and State Agricultural College | Burlington | Vermont | United States | 05405 |
| 137 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 138 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 139 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 140 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 141 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 142 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 143 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Srivandana Akshintala, Children's Oncology Group
Study Documents (Full-Text)
More Information
Publications
None provided.- NCI-2016-01258
- NCI-2016-01258
- ADVL1622
- ADVL1622
- ADVL1622
- U10CA180886