Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026312
First received: November 9, 2001
Last updated: July 30, 2015
Last verified: July 2015
  Purpose

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.


Condition Intervention Phase
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Biological: Aldesleukin
Biological: Dinutuximab
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Biological: Sargramostim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • EFS [ Time Frame: From study enrollment until the first occurrence of an event or until last contact with the patient if no event occurs, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be generated and log rank tests will be performed.


Secondary Outcome Measures:
  • EFS of patients from the non-randomized portion of the trial [ Time Frame: From study enrollment until the first occurrence of an event or until last contact with the patient if no event occurs, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves of EFS and OS will be generated, including 95% confidence intervals on the curves.

  • Historical data for the analogous patients [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A historical comparison will be made. This comparison will be a descriptive one only.

  • Incidence of toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Descriptive analyses of toxicity will be performed over all patients.

  • Number of courses of therapy delivered [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A Wilcoxon test will be used to compare the number of courses of therapy delivered.

  • OS [ Time Frame: From study enrollment until death or until last contact with the patient if the patient does not die, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be generated and log rank tests will be performed.

  • OS of patients from the non-randomized portion of the trial [ Time Frame: From study enrollment until death or until last contact with the patient if the patient does not die, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves of EFS and OS will be generated, including 95% confidence intervals on the curves.


Other Outcome Measures:
  • Average level of HACA [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The average level of HACA at each collection time point during immunotherapy will be calculated.

  • Cardiac repolarization [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.

  • Change in MRD [ Time Frame: Baseline to up to 10 years ] [ Designated as safety issue: No ]
    A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.

  • Change in tumor biology [ Time Frame: Baseline to up to 10 years ] [ Designated as safety issue: No ]
    A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS.

  • Circulating B7-H6 levels [ Time Frame: 1 week before first sargramostim injection (day -1 of course 1) ] [ Designated as safety issue: No ]
    Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.

  • Genotype of FcR [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.

  • Genotype of Kir/Kir-ligand [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.

  • Isotretinoin pharmacokinetic parameters [ Time Frame: At 4 hours after administration on day 14 of course 1 ] [ Designated as safety issue: No ]
    To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall's Tau statistic will be calculated.

  • Levels of ADCC [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Will be descriptively compared.

  • NKp30 isoform expression and SNP [ Time Frame: 1 week before first sargramostim injection (day -1 of course 1) ] [ Designated as safety issue: No ]
    Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.

  • Presence of naturally occurring anti-glycan antibodies [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    A Fisher's exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab.


Estimated Enrollment: 1660
Study Start Date: October 2001
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
Beginning on day 67 post-ASCT, patients receive isotretinoin PO BID for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.
Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • ISOTRETINOIN
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim SC or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.
Biological: Aldesleukin
Given IV
Other Names:
  • 125-L-Serine-2-133-interleukin 2
  • ALDESLEUKIN
  • Proleukin
  • r-serHuIL-2
  • Recombinant Human IL-2
  • Recombinant Human Interleukin-2
Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • DINUTUXIMAB
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin
Drug: Isotretinoin
Given PO
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • ISOTRETINOIN
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Biological: Sargramostim
Given IV or SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin
  • SARGRAMOSTIM

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must be diagnosed with neuroblastoma, and categorized as high risk at the time of diagnosis; exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible
  • All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include:

    • Following treatment per A3973 protocol
    • Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol
    • Following treatment per CCG3891
    • Following treatment on New Approaches to Neuroblastoma Therapy (NANT) 2001-02
    • Enrollment on or following treatment per ANBL02P1
    • Enrollment on or following treatment per ANBL07P1
    • Tandem transplant patients are eligible:

      • Following treatment on or per ANBL0532
      • Following treatment per POG 9640
      • Following treatment per COG ANBL00P1
      • Following treatment per CHP 594/Dana-Farber Cancer Institute (DFCI) 34-DAT
  • No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below; for tandem ASCT patients, this will be the date of the FIRST stem cell infusion; exception: for those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 12 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT
  • At pre-ASCT evaluation patients must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below:

    • =< 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy
    • Patient who have no tumor seen on the prior bone marrow, and then have =< 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible (note that per INRC this would have been defined as "overall" response of progressive disease [PD])
  • Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including computed tomography [CT] or magnetic resonance imaging [MRI], MIBG scan, and vanillylmandelic acid [VMA]/homovanillic acid [HVA]; bone marrow aspirates are required but biopsy may be omitted if negative prior to ASCT); this disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before enrollment

    • For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest 5 days after completing radiotherapy; patients with residual disease are eligible; biopsy is not required; patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum 07
    • Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response and except for elevations of catecholamines as the only sign of disease in a patient who had normal catecholamines at pre-ASCT evaluation
  • Patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than ten (10) calendar days after the date of study enrollment; patients should be enrolled preferably between day 56 and day 85 after peripheral blood stem cell (PBSC) infusion (day from 2nd stem cell infusion for tandem transplant); patients must be enrolled no later than day 200 after PBSC infusion; enrollment must occur after completion of radiotherapy, and after completion of tumor assessment post-ASCT and radiotherapy; informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration
  • Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy
  • Patients must have a Lansky or Karnofsky performance scale score of >= 50% and patients must have a life expectancy of >= 2 months
  • Total absolute phagocyte count (APC = %neutrophils + %monocytes) X white blood cell (WBC) is at least 1000/uL
  • 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:

    • No greater than 0.4 mg/dL (1 month to < 6 months)
    • No greater than 0.5 mg/dL (6 months to < 1 year)
    • No greater than 0.6 mg/dL (1 to < 2 years)
    • No greater than 0.8 mg/dL (2 to < 6 years)
    • No greater than 1.0 mg/dL (6 to < 10 years)
    • No greater than 1.2 mg/dL (10 to < 13 years)
    • No greater than 1.4 mg/dL (>= 13 years [female])
    • No greater than 1.5 mg/dL (13 to < 16 years [male])
    • No greater than 1.7 mg/dL (>= 16 years [male])
  • Total bilirubin =< 1.5 x normal
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x normal
  • Veno-occlusive disease, if present, should be stable or improving
  • Shortening fraction of >= 27% by echocardiogram, or if shortening fraction abnormal, ejection fraction of >= 55% by gated radionuclide study or echocardiogram; note: the echocardiogram or gated radionuclide study must be performed within 4 weeks prior to enrollment
  • Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) > 60% predicted by pulmonary function test; for children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest and no exercise intolerance should be documented; note: the pulmonary function test must be performed within 4 weeks prior to enrollment
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well-controlled; central nervous system (CNS) toxicity < grade 2
  • Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
  • Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026312

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Cancer Center Withdrawn
Birmingham, Alabama, United States, 35233
United States, Alaska
Providence Alaska Medical Center Active, not recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Phoenix Childrens Hospital Active, not recruiting
Phoenix, Arizona, United States, 85016
The University of Arizona Medical Center-University Campus Active, not recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202-3591
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Active, not recruiting
Downey, California, United States, 90242
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Alice L. Yu    619-543-2438    aliceyu@ucsd.edu   
Principal Investigator: Alice L. Yu         
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Miller Children's and Women's Hospital Long Beach Active, not recruiting
Long Beach, California, United States, 90806
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Children's Hospital and Research Center at Oakland Active, not recruiting
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland Active, not recruiting
Oakland, California, United States, 94611
Childrens Hospital of Orange County Active, not recruiting
Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Alice L. Yu    619-543-2438    aliceyu@ucsd.edu   
Principal Investigator: Alice L. Yu         
University of California Davis Comprehensive Cancer Center Active, not recruiting
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego Active, not recruiting
San Diego, California, United States, 92123
UCSF Medical Center-Mission Bay Active, not recruiting
San Francisco, California, United States, 94158
UCSF Medical Center-Parnassus Withdrawn
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Brian S. Greffe    720-777-6672      
Principal Investigator: Brian S. Greffe         
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Active, not recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center Active, not recruiting
Hartford, Connecticut, United States, 06106
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Alice L. Yu    619-543-2438    aliceyu@ucsd.edu   
Principal Investigator: Alice L. Yu         
United States, Florida
Broward Health Medical Center Active, not recruiting
Fort Lauderdale, Florida, United States, 33316
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Active, not recruiting
Fort Myers, Florida, United States, 33908
University of Florida Active, not recruiting
Gainesville, Florida, United States, 32610
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Active, not recruiting
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott M. Bradfield    904-697-3529      
Principal Investigator: Scott M. Bradfield         
Baptist Hospital of Miami Active, not recruiting
Miami, Florida, United States, 33176
Nicklaus Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
University of Miami Miller School of Medicine-Sylvester Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Vincent F. Giusti         
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Active, not recruiting
Orlando, Florida, United States, 32827
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
All Children's Hospital Active, not recruiting
Saint Petersburg, Florida, United States, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa Active, not recruiting
Tampa, Florida, United States, 33607
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Georgia Regents University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: Colleen H. McDonough         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
Tripler Army Medical Center Active, not recruiting
Honolulu, Hawaii, United States, 96859
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
United States, Illinois
Lurie Children's Hospital-Chicago Active, not recruiting
Chicago, Illinois, United States, 60611
University of Illinois Active, not recruiting
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Navin R. Pinto    773-834-7424      
Principal Investigator: Navin R. Pinto         
Advocate Children's Hospital-Oak Lawn Active, not recruiting
Oak Lawn, Illinois, United States, 60453
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Karen S. Fernandez    309-655-3258      
Principal Investigator: Karen S. Fernandez         
Southern Illinois University School of Medicine Active, not recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194      
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Active, not recruiting
Des Moines, Iowa, United States, 50309
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kentucky
University of Kentucky/Markey Cancer Center Active, not recruiting
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Children's Hospital New Orleans Active, not recruiting
New Orleans, Louisiana, United States, 70118
United States, Maine
Maine Children's Cancer Program Active, not recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21287
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
University of Maryland/Greenebaum Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo    877-442-3324      
Principal Investigator: Carlos Rodriguez-Galindo         
Floating Hospital for Children at Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Howard J. Weinstein    877-726-5130      
Principal Investigator: Howard J. Weinstein         
Baystate Medical Center Active, not recruiting
Springfield, Massachusetts, United States, 01199
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Saint John Hospital and Medical Center Active, not recruiting
Detroit, Michigan, United States, 48236
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Michigan State University Clinical Center Active, not recruiting
East Lansing, Michigan, United States, 48824-7016
Hurley Medical Center Active, not recruiting
Flint, Michigan, United States, 48502
Helen DeVos Children's Hospital at Spectrum Health Active, not recruiting
Grand Rapids, Michigan, United States, 49503
Bronson Methodist Hospital Active, not recruiting
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily G. Greengard    612-624-2620      
Principal Investigator: Emily G. Greengard         
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
The Childrens Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63104
Mercy Hospital Saint Louis Active, not recruiting
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David B. Wilson    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: David B. Wilson         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Active, not recruiting
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68198
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Nik Farahana N. Rashid    702-384-0013      
Principal Investigator: Nik Farahana N. Rashid         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07960
UMDNJ - Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Alice L. Yu    619-543-2438    aliceyu@ucsd.edu   
Principal Investigator: Alice L. Yu         
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Vikramjit S. Kanwar    518-262-3368      
Principal Investigator: Vikramjit S. Kanwar         
Montefiore Medical Center - Moses Campus Active, not recruiting
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476      
Principal Investigator: Mark E. Weinblatt         
The Steven and Alexandra Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jonathan D. Fish    718-470-3470      
Principal Investigator: Jonathan D. Fish         
Laura and Issac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Sharon L. Gardner    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Sharon L. Gardner         
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Mount Sinai Medical Center Active, not recruiting
New York, New York, United States, 10029
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
New York Medical College Active, not recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospital-Memorial Campus Active, not recruiting
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center-Fargo Active, not recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Active, not recruiting
Dayton, Ohio, United States, 45404
The Toledo Hospital/Toledo Children's Hospital Active, not recruiting
Toledo, Ohio, United States, 43606
Mercy Children's Hospital Terminated
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Children's Hospital Active, not recruiting
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Active, not recruiting
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Jagadeesh Ramdas    570-271-5251      
Principal Investigator: Jagadeesh Ramdas         
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: John M. Maris    215-590-2810      
Principal Investigator: John M. Maris         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Akash Nahar    215-427-8991      
Principal Investigator: Akash Nahar         
Children's Hospital of Pittsburgh of UPMC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Palmetto Health Richland Active, not recruiting
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Cary E. Stroud    864-241-6251      
Principal Investigator: Cary E. Stroud         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Active, not recruiting
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
T C Thompson Children's Hospital Active, not recruiting
Chattanooga, Tennessee, United States, 37403
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    866-278-5833    info@stjude.org   
Principal Investigator: Wayne L. Furman         
Vanderbilt University/Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Children's Medical Center of Central Texas Active, not recruiting
Austin, Texas, United States, 78723
Driscoll Children's Hospital Active, not recruiting
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital Active, not recruiting
Dallas, Texas, United States, 75230
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Tanya C. Watt    214-648-7097      
Principal Investigator: Tanya C. Watt         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Mary Meaghan P. Granger    682-885-2103      
Principal Investigator: Mary Meaghan P. Granger         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Karen R. Rabin    713-798-1354    burton@bcm.edu   
Principal Investigator: Karen R. Rabin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Jaime Estrada    210-575-7000      
Principal Investigator: Jaime Estrada         
University of Texas Health Science Center at San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Primary Children's Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84113
United States, Vermont
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Alan C. Homans    802-656-4101      
Principal Investigator: Alan C. Homans         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore    434-243-6143      
Principal Investigator: Kimberly P. Dunsmore         
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Marshall A. Schorin    703-208-6650      
Principal Investigator: Marshall A. Schorin         
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
Naval Medical Center - Portsmouth Active, not recruiting
Portsmouth, Virginia, United States, 23708-2197
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Gita V. Massey    804-628-1939      
Principal Investigator: Gita V. Massey         
Carilion Clinic Children's Hospital Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
United States, West Virginia
West Virginia University Healthcare Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Alice L. Yu    619-543-2438    aliceyu@ucsd.edu   
Principal Investigator: Alice L. Yu         
United States, Wisconsin
Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly    414-805-4380      
Principal Investigator: Michael E. Kelly         
Australia, New South Wales
John Hunter Children's Hospital Active, not recruiting
Hunter Regional Mail Centre, New South Wales, Australia, 2310
Sydney Children's Hospital Active, not recruiting
Randwick, New South Wales, Australia, 2031
The Children's Hospital at Westmead Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Royal Children's Hospital-Brisbane Withdrawn
Herston, Queensland, Australia, 4029
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
Australia, South Australia
Women's and Children's Hospital-Adelaide Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby    (08) 8161 7327    cywhs.oncsec@health.sa.gov.au   
Principal Investigator: Maria L. Kirby         
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud       crdo.info@mcri.edu.au   
Principal Investigator: Francoise M. Mechinaud         
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-2345 ext 6477      
Principal Investigator: Caron Strahlendorf         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    866-561-1026    CIO_Web@cancercare.mb.ca   
Principal Investigator: Rochelle A. Yanofsky         
Canada, Newfoundland and Labrador
Janeway Child Health Centre Active, not recruiting
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Chedoke Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100 ext 74595      
Principal Investigator: Carol Portwine         
McMaster Children's Hospital at Hamilton Health Sciences Active, not recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital Active, not recruiting
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sarah W. Alexander    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Sarah W. Alexander         
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital of the MUHC Active, not recruiting
Montreal, Quebec, Canada, H3H 1P3
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon    418-525-4444      
Principal Investigator: Bruno Michon         
New Zealand
Starship Children's Hospital Active, not recruiting
Grafton, Auckland, New Zealand, 1145
Christchurch Hospital Active, not recruiting
Christchurch, New Zealand, 8011
Puerto Rico
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Luis A. Clavell    787-765-2363      
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
Investigators
Principal Investigator: Alice Yu Children's Oncology Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026312     History of Changes
Other Study ID Numbers: NCI-2009-01064, NCI-2009-01064, CDR0000069018, COG-ANBL0032, PANBL0032_A33PAMDREVW01, ANBL0032, ANBL0032, U10CA180886, U10CA030969, U10CA098543
Study First Received: November 9, 2001
Last Updated: July 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Aldesleukin
Interleukin-2
Isotretinoin
Tretinoin
Analgesics
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Dermatologic Agents
Keratolytic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015