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Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors

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ClinicalTrials.gov Identifier: NCT02867592
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Adrenal Cortex Carcinoma Adult Alveolar Soft Part Sarcoma Adult Clear Cell Sarcoma of Soft Parts Adult Hepatocellular Carcinoma Adult Rhabdomyosarcoma Adult Soft Tissue Sarcoma Childhood Alveolar Soft Part Sarcoma Childhood Central Nervous System Neoplasm Childhood Clear Cell Sarcoma of Soft Parts Childhood Hepatocellular Carcinoma Childhood Rhabdomyosarcoma Childhood Soft Tissue Sarcoma Childhood Solid Neoplasm Ewing Sarcoma Hepatoblastoma Hepatocellular Carcinoma Recurrent Adrenal Cortex Carcinoma Recurrent Adult Hepatocellular Carcinoma Recurrent Adult Soft Tissue Sarcoma Recurrent Alveolar Soft Part Sarcoma Recurrent Childhood Central Nervous System Neoplasm Recurrent Childhood Hepatocellular Carcinoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Malignant Solid Neoplasm Recurrent Osteosarcoma Recurrent Renal Cell Carcinoma Recurrent Rhabdomyosarcoma Refractory Osteosarcoma Renal Cell Carcinoma Thyroid Gland Medullary Carcinoma Wilms Tumor Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis Other: Pharmacological Study Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults.

II. 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:

I. To further define XL184 related toxicities in pediatric, adolescent and young adult patients.

II. To further define XL184 pharmacokinetics in the pediatric and adolescent patients.

III. 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.

TERTIARY OBJECTIVES:

I. 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) once daily (QD) on days 1-28. Courses 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults With Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : November 21, 2018
Estimated Study Completion Date : November 21, 2018


Arm Intervention/treatment
Experimental: Treatment (cabozantinib s-malate)
Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Given PO
Other Names:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL184

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacological Study
Correlative studies




Primary Outcome Measures :
  1. Objective response assessed by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 1 year ]
    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. Will be assessed using the exact conditional test of proportions.


Secondary Outcome Measures :
  1. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]
    Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.

  2. Pharmacokinetics (PK) parameters of cabozantinib s-malate [ Time Frame: Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1, and prior to dose and 2-4 hours after dose on day 22 of course 1, prior to dose on day 1 of courses 2 and 3 ]
    The PK parameters such as peak concentration, time to peak concentration, area under the curve, apparent clearance, half-life, and steady state concentration will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. Will also be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).


Other Outcome Measures:
  1. Progression free survival (PFS) [ Time Frame: Up to 1 year ]
    Will be assessed using the log-rank test with hazard ratios estimated from a Cox proportional hazards regression model. Will compare PFS to historical controls.

  2. Change in immune biomarkers [ Time Frame: Baseline up to course 3, day 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)
  • Patients must have a body surface area >= 0.35 m^2
  • 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:

    • Ewing sarcoma
    • Rhabdomyosarcoma (RMS)
    • Non-rhabdomyosarcoma soft tissue sarcomas (STS) including microphthalmia transcription factor associated STS (alveolar soft part sarcoma [ASPS] and clear cell sarcoma [CCS])
    • Osteosarcoma
    • Wilms tumor
    • Rare tumors

      • Medullary thyroid carcinoma (MTC)
      • Renal cell carcinoma (RCC)
      • Hepatocellular carcinoma (HCC)
      • Hepatoblastoma
      • Adrenocortical carcinoma
      • 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
  • 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)

    • Note: The following do NOT qualify as measurable disease:

      • Malignant fluid collections (e.g., ascites, pleural effusions)
      • Bone marrow infiltration
      • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans)
      • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
      • Previously radiated lesions that have not demonstrated clear progression post radiation
      • Leptomeningeal lesions that do not meet the measurement parameters noted above
  • 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
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
  • 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
  • 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
  • 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
  • >= 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

    • Subjects should not have any clinically relevant ongoing complications from prior radiation therapy (i.e., radiation esophagitis or other inflammation of the viscera)
  • No evidence of active graft versus (vs.) host disease and >= 2 months must have elapsed since transplant
  • 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
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL for patients with solid tumors without bone marrow involvement
  • 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
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) for patients with solid tumors without bone marrow involvement
  • Peripheral absolute neutrophil count (ANC) >= 750/uL for patients with solid tumors and known bone marrow metastatic disease
  • Platelet count >= 50,000/uL for patients with solid tumors and known bone marrow metastatic disease
  • Hemoglobin >= 8.0 g/dL for patients with solid tumors and known bone marrow metastatic disease
  • Transfusions are permitted to meet both the platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet 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:

    • 2 to < 6 years of age

      • Male and female: 0.8 (maximum serum creatinine [mg/dL])
    • 6 to < 10 years of age

      • Male and female: 1 (maximum serum creatinine [mg/dL])
    • 10 to < 13 years of age

      • Male and female: 1.2 (maximum serum creatinine [mg/dL])
    • 13 to < 16 years of age

      • Male 1.5 (maximum serum creatinine [mg/dL])
      • Female: 1.4 (maximum serum creatinine [mg/dL])
    • >= 16 years of age

      • Male: 1.7 (maximum serum creatinine [mg/dL])
      • Female: 1.4 (maximum serum creatinine [mg/dL])
  • Urine protein: =< 30 mg/dl in urinalysis or =< 1+ on dipstick, unless quantitative protein is < 1000 mg in a 24 hour (h) urine sample
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • 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)
  • Serum albumin >= 2.8 g/dL
  • No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
  • No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment
  • 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)
  • Patients with a known seizure disorder who are receiving non-enzyme inducing anticonvulsants and have well-controlled seizures may be enrolled
  • CNS toxicity =< grade 2
  • 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
  • International normalized ratio (INR) =< 1.5
  • Serum amylase =< 1.5 ULN
  • Serum lipase =< 1.5 ULN

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study; 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
  • 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)
  • 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
  • Previous treatment with XL184 (cabozantinib) or another MET/HGF inhibitor (tivantinib, crizotinib)
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • 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
  • 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
  • Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin, and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) are prohibited

    • 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
  • Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
  • Patients who are receiving drugs that prolong QTc are not eligible
  • Patients who are unable to swallow intact tablets are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • 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
  • 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
  • Patients who have had or are planning to have the following invasive procedures are not eligible:

    • Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment
    • 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
    • Core biopsy within 7 days prior to enrollment
    • Fine needle aspirate within 7 days prior to enrollment
    • Surgical or other wounds must be adequately healed prior to enrollment
    • 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
  • Patients who have had significant traumatic injury within 28 days prior to enrollment are not eligible
  • Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of the study drug are not eligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867592


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gregory K. Friedman         
United States, Alaska
Providence Alaska Medical Center Suspended
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: David L. Becton         
United States, California
Kaiser Permanente-Anaheim Suspended
Anaheim, California, United States, 92806
Kaiser Permanente-Bellflower Suspended
Bellflower, California, United States, 90706
Kaiser Permanente Downey Medical Center Recruiting
Downey, California, United States, 90242
Contact: Site Public Contact    626-564-3455      
Principal Investigator: Robert M. Cooper         
Kaiser Permanente-Fontana Suspended
Fontana, California, United States, 92335
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Kaiser Permanente Los Angeles Medical Center Suspended
Los Angeles, California, United States, 90027
Valley Children's Hospital Recruiting
Madera, California, United States, 93636
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carla B. Golden         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elyssa M. Rubin         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Sheri L. Spunt         
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Site Public Contact    916-734-3089      
Principal Investigator: Marcio H. Malogolowkin         
Kaiser Permanente-San Diego Mission Suspended
San Diego, California, United States, 92108
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William D. Roberts         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Kieuhoa T. Vo         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Margaret E. Macy         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jennifer J. Clark         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael S. Isakoff         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Site Public Contact    302-651-6884    dperry@nemours.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
Kaiser Permanente-Capitol Hill Medical Center Suspended
Washington, District of Columbia, United States, 20002
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: AeRang Kim         
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emad K. Salman         
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William B. Slayton         
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Site Public Contact    305-243-2647      
Principal Investigator: Julio C. Barredo         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Site Public Contact    407-303-2090    FH.Cancer.Research@flhosp.org   
Principal Investigator: Fouad M. Hajjar         
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-843-2584    melissa.leffin@orlandohealth.com   
Principal Investigator: Don E. Eslin         
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jonathan L. Metts         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: William T. Cash         
United States, Hawaii
Straub Clinic and Hospital Suspended
Honolulu, Hawaii, United States, 96813
Kaiser Permanente Moanalua Medical Center Suspended
Honolulu, Hawaii, United States, 96819
Kapiolani Medical Center for Women and Children Suspended
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
University of Illinois Suspended
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Ami V. Desai         
Carle on Vermilion Recruiting
Danville, Illinois, United States, 61832
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: James R. Egner         
Carle Physician Group-Effingham Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: James R. Egner         
Carle Physician Group-Mattoon/Charleston Recruiting
Mattoon, Illinois, United States, 61938
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: James R. Egner         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Site Public Contact    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: James R. Egner         
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: James R. Egner         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    800-248-1199      
Principal Investigator: Kamnesh R. Pradhan         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Public Contact    317-338-2194    research@stvincent.org   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wendy L. Woods-Swafford         
Iowa Methodist Medical Center Suspended
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital Suspended
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Site Public Contact    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Site Public Contact    859-257-3379      
Principal Investigator: Vlad C. Radulescu         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kerry K. McGowan         
United States, Louisiana
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Lolie C. Yu         
United States, Maine
Eastern Maine Medical Center Suspended
Bangor, Maine, United States, 04401
Lafayette Family Cancer Center-EMMC Suspended
Brewer, Maine, United States, 04412
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Site Public Contact    410-601-6120    pridgely@lifebridgehealth.org   
Principal Investigator: Jason M. Fixler         
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Site Public Contact    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Christine A. Pratilas         
National Institutes of Health Clinical Center Suspended
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Site Public Contact    877-726-5130      
Principal Investigator: Suzanne Shusterman         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: Suzanne Shusterman         
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rajen Mody         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Site Public Contact    313-576-9790    ctoadmin@karmanos.org   
Principal Investigator: Roland L. Chu         
Ascension Saint John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Adonis N. Lorenzana         
Huron Medical Center PC Suspended
Port Huron, Michigan, United States, 48060
Beaumont Children's Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Site Public Contact    248-551-0360      
Principal Investigator: Laura K. Gowans         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Emily G. Greengard         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Carola A. Arndt         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Site Public Contact    601-815-6700      
Principal Investigator: Anderson (Andy) B. Collier         
United States, Missouri
Siteman Cancer Center at West County Hospital Suspended
Creve Coeur, Missouri, United States, 63141
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Keith J. August         
Barnes-Jewish Hospital Suspended
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
Siteman Cancer Center-South County Suspended
Saint Louis, Missouri, United States, 63129
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Site Public Contact    314-251-6770      
Principal Investigator: Bethany G. Sleckman         
Siteman Cancer Center at Saint Peters Hospital Suspended
Saint Peters, Missouri, United States, 63376
United States, Nevada
Comprehensive Cancer Centers of Nevada-Horizon Ridge Suspended
Henderson, Nevada, United States, 89052
Children's Specialty Center of Nevada II Suspended
Las Vegas, Nevada, United States, 89109
Sunrise Hospital and Medical Center Suspended
Las Vegas, Nevada, United States, 89109
Summerlin Hospital Medical Center Suspended
Las Vegas, Nevada, United States, 89144
Hope Cancer Care of Nevada-Pahrump Suspended
Pahrump, Nevada, United States, 89048
Radiation Oncology Associates Suspended
Reno, Nevada, United States, 89509
United States, New Hampshire
Dartmouth Hitchcock Medical Center Suspended
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Site Public Contact    973-971-5900      
Principal Investigator: Steven L. Halpern         
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Suspended
New Brunswick, New Jersey, United States, 08903
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Clare J. Twist         
NYU Winthrop Hospital Suspended
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Julie I. Krystal         
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Site Public Contact    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Alice Lee         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Site Public Contact    315-464-5476      
Principal Investigator: Philip M. Monteleone         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Susan G. Kreissman         
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Site Public Contact    252-744-1015    eubankss@ecu.edu   
Principal Investigator: Andrea R. Whitfield         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: James I. Geller         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    216-844-5437      
Principal Investigator: John J. Letterio         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Aron Flagg         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
ProMedica Flower Hospital Suspended
Sylvania, Ohio, United States, 43560
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jamie L. Dargart         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Site Public Contact    503-494-1080    trials@ohsu.edu   
Principal Investigator: Linda C. Stork         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Elizabeth Fox         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jean M. Tersak         
United States, South Carolina
Saint Francis Hospital Suspended
Greenville, South Carolina, United States, 29601
BI-LO Charities Children's Cancer Center Suspended
Greenville, South Carolina, United States, 29605
Saint Francis Cancer Center Suspended
Greenville, South Carolina, United States, 29607
United States, Tennessee
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Site Public Contact    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wayne L. Furman         
The Children's Hospital at TriStar Centennial Suspended
Nashville, Tennessee, United States, 37203
United States, Texas
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Site Public Contact    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: Theodore W. Laetsch         
El Paso Children's Hospital Suspended
El Paso, Texas, United States, 79905
Texas Tech University Health Sciences Center-El Paso Suspended
El Paso, Texas, United States, 79905
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    713-798-1354    burton@bcm.edu   
Principal Investigator: Jodi Muscal         
United States, Vermont
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Site Public Contact    802-656-8990      
Principal Investigator: Jessica L. Heath         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Site Public Contact    434-243-6303    PAS9E@virginia.edu   
Principal Investigator: William C. Petersen         
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Julie R. Park         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Site Public Contact       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
United States, Wisconsin
Gundersen Lutheran Medical Center Suspended
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Kenneth B. De Santes         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Michael J. Burke         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Srivandana Akshintala Children's Oncology Group

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02867592     History of Changes
Other Study ID Numbers: NCI-2016-01258
NCI-2016-01258 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ADVL1622
ADVL1622 ( Other Identifier: Childrens Oncology Group )
ADVL1622 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Wilms Tumor
Nervous System Neoplasms
Central Nervous System Neoplasms
Thyroid Neoplasms
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Neoplasms by Site
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Carcinoma
Sarcoma