Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

This study has suspended participant recruitment.
(Temporarily stopped for assessment.)
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: January 9, 2013
Last updated: October 27, 2015
Last verified: July 2015
This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, 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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.

Condition Intervention Phase
Recurrent Neuroblastoma
Biological: Dinutuximab
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Sargramostim
Drug: Temozolomide
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Proportion of patients who are responders defined as patients who achieve a >= partial response (PR) per the INRC as their best overall response [ Time Frame: Up to 18 weeks ] [ Designated as safety issue: No ]
    Compared between treatment arms using a Fisher's exact test.

Secondary Outcome Measures:
  • Ability to maintain intended treatment with all agents (irinotecan hydrochloride, temozolomide and the experimental agent) without a dose reduction or going off protocol therapy for toxicity [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Occurrence of unacceptable toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Overall response rate (complete response, PR, stable disease, progressive disease) according to the INRC [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Compared between treatment arms using a Fisher's exact test.

  • Overall survival [ Time Frame: Time of enrollment on the study until the occurrence of the first event or until the time of last contact if no event has occurred, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be generated, and curves will be compared using a log-rank test.

  • Progression-free survival, defined as a relapse, progressive disease, or death attributable to tumor or treatment [ Time Frame: Time of enrollment on the study until the occurrence of the first event or until the time of last contact if no event has occurred, assessed up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves will be generated, and curves will be compared using a log-rank test.

Estimated Enrollment: 74
Study Start Date: February 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (temozolomide, irinotecan hydrochloride, temsirolimus)
Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.
Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • U-101440E
Other: Laboratory Biomarker Analysis
Optional correlative studies
Drug: Temozolomide
Given PO
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temodal
  • Temodar
Drug: Temsirolimus
Given IV
Other Names:
  • CCI-779
  • CCI-779 Rapamycin Analog
  • Cell Cycle Inhibitor 779
  • Rapamycin Analog
  • Rapamycin Analog CCI-779
  • Torisel
Experimental: Arm II (temozolomide, irinotecan hydrochloride, dinutuximab)
Patients receive temozolomide and irinotecan hydrochloride as in Arm I, dinutuximab IV over 10-20 hours on days 2-5 and sargramostim SC or IV over 2 hours on days 6-12.
Biological: Dinutuximab
Given IV
Other Names:
  • Ch 14.18UTC
  • Ch14.18
  • MOAB Ch14.18
  • monoclonal antibody Ch14.18
  • Unituxin
Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • U-101440E
Other: Laboratory Biomarker Analysis
Optional correlative studies
Biological: Sargramostim
Given SC or IV
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin
Drug: Temozolomide
Given PO
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temodal
  • Temodar

Detailed Description:


I. To identify whether temsirolimus or ch14.18 (dinutuximab) is the optimal therapeutic agent to consider for further testing in a future Phase III randomized trial for treatment of newly diagnosed high-risk neuroblastoma.


I. To compare the response rates (RR) for patients receiving temsirolimus or ch14.18 in combination with irinotecan (irinotecan hydrochloride) and temozolomide.

II. To compare the progression free survival (PFS) and overall survival (OS) rates for patients receiving temsirolimus or ch14.18 in combination with irinotecan and temozolomide.

III. To compare the toxicities associated with temsirolimus or ch14.18 when combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

IV. To compare the ability to maintain intended dose intensity of all agents when temsirolimus or ch14.18 is combined with irinotecan and temozolomide in patients with refractory, relapsed or progressive neuroblastoma.

V. To determine the concordance between tumor responses as defined by standard International Neuroblastoma Response Criteria (INRC) versus response per the revised INRC.

VI. To study the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 antibody.

VII. To study the clinical relevance of natural killer (NK) receptor natural cytotoxicity triggering receptor 3 (NKp30) isoforms in patients receiving ch14.18 antibody or temsirolimus.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive temozolomide orally (PO) on days 1-5, irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1-5, and temsirolimus IV over 30 minutes on days 1 and 8.

ARM II: Patients receive temozolomide and irinotecan hydrochloride as in Arm I, dinutuximab IV over 10-20 hours on days 2-5 and sargramostim subcutaneously (SC) or IV over 2 hours on days 6-12.

In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e., > 2 x upper limit of normal [ULN]), at the time of initial diagnosis
  • For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:

    • First episode of recurrent disease following completion of aggressive multi-drug frontline therapy
    • First episode of progressive disease during aggressive multi-drug frontline therapy
    • Primary resistant/refractory disease detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, etc.)
  • Patients must have at least ONE of the following:

    • Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan obtained within 3 weeks prior to study entry; measurable is defined as >= 10 mm in at least one dimension on spiral/helical CT that is metaiodobenzylguanidine (MIBG) avid or demonstrates increased fludeoxyglucose (FDG) uptake on positron emission tomography (PET) scan
    • MIBG scan obtained within 3 weeks prior to study entry with positive uptake at a minimum of one site; this site must represent disease recurrence after completion of therapy, progressive disease on therapy, or refractory disease during induction
    • Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma; biopsy is not required for patients who have new site of soft tissue disease (radiographic evidence of disease progression) regardless of whether progression occurs while receiving therapy or after completion of therapy
    • Note: Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have received frontline therapy (including surgery, chemotherapy, autologous stem cell transplant [SCT] +/- MIBG, immunotherapy, radiotherapy, and retinoids) but may NOT have received second line chemotherapy for resistant/refractory, relapsed disease or progressive disease
  • At least 14 days must have elapsed since completion of myelosuppressive therapy
  • At least 7 days must have elapsed since the completion of therapy with a non-myelosuppressive biologic agent or retinoid
  • No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions; however, patients must not have received radiation for a minimum of 4 weeks prior to study entry at the site of any lesion that will be identified as a target lesion to measure tumor response; lesions that have been previously radiated cannot be used as target lesions unless there is radiographic evidence of progression at the site following radiation or a biopsy done following radiation shows viable neuroblastoma; palliative radiation is allowed to sites that will not be used to measure response during this study
  • Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions as long as hematologic and other eligibility criteria have been met
  • Patients are eligible >= 6 weeks after therapeutic 131I-MIBG provided that all other eligibility criteria are met
  • Subjects who have previously received anti-disialoganglioside (GD2) monoclonal antibodies for biologic therapy or for tumor imaging are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads, but no other form of anti-GD2 monoclonal antibody, are eligible
  • Patients must not have received long-acting myeloid growth factors (e.g., Neulasta) within 14 days of entry on this study; seven days must have elapsed since administration of a short acting myeloid growth factor
  • Peripheral absolute neutrophil count (ANC) >= 750/uL
  • Platelet count >= 75,000/uL (transfusion independent)
  • Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and platelet count criteria are met but are not evaluable for hematological toxicity
  • Creatinine clearance or estimated radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
  • A serum creatinine =< upper limit of normal (ULN) based on age/gender as follows:

    • Age 1 month to < 6 months: 0.4 for males, 0.4 for females
    • Age 6 months to < 1 year: 0.5 for males, 0.5 for females
    • Age 1 to < 2 years: 0.6 for males, 0.6 for females
    • Age 2 to < 6 years: 0.8 for males, 0.8 for females
    • Age 6 to < 10 years: 1 for males, 1 for females
    • Age 10 to < 13 years: 1.2 for males, 1.2 for females
    • Age 13 to < 16 years: 1.5 for males, 1.4 for females
    • Age >= 16 years: 1.7 for males, 1.4 for females
  • Total bilirubin =< 1.5 x ULN for age AND
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L); for the purpose of this study, the ULN for SGPT is 45 U/L
  • Adequate central nervous system function defined as:

    • Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of study enrollment
    • Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsants
    • CNS toxicity =< grade 2
  • Shortening fraction of >= 27% by echocardiogram (ECHO) OR
  • Ejection fraction >= 50% by ECHO or gated radionuclide study
  • Adequate coagulation defined as:

    • Prothrombin time (PT) =< 1.2 x upper limit of normal
  • Serum lipids within acceptable range:

    • Serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; If non-fasting values exceed these levels, lipid testing should be repeated in the fasting state
  • Adequate pulmonary function defined as:

    • No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry; normal pulmonary function tests in patients who are capable of cooperating with testing (including diffusion capacity of the lung of carbon monoxide [DLCO]) are required if there is a clinical indication for determination; for patients who do not have respiratory symptoms, full pulmonary function tests (PFTs) are NOT required

Exclusion Criteria:

  • Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study; based on the established teratogenic potential of alkylating agents and temsirolimus, pregnant women will be excluded from this study; because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study; females of childbearing potential must have a negative pregnancy test to be eligible for this study
  • Patients with elevated catecholamines (i.e., > 2 x ULN) only or bone marrow disease only are NOT eligible for this study
  • Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment; patients who require or are likely to require pharmacologic doses of systemic corticosteroids while receiving treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product administration in order to avoid allergic transfusion reactions; the use of conventional doses of inhaled steroids for the treatment of asthma is permitted, as is the use of physiologic doses of steroids for patients with known adrenal insufficiency
  • Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, valproic acid, or carbamazepine for at least 7 days prior to study enrollment; patients receiving non-enzyme inducing anticonvulsants such as gabapentin or levetiracetam will be eligible
  • Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma
  • Patients with symptoms of congestive heart failure are not eligible
  • Patients must not have >= grade 2 diarrhea
  • Patients must not have uncontrolled infection
  • Patients who have received prior therapy with an mammalian target of rapamycin (mTOR) inhibitor in combination with cytotoxic chemotherapy are not eligible
  • Patients with a history of significant allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus are not eligible
  • Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required discontinuation of the anti-GD2 therapy are not eligible
  • Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible
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Please refer to this study by its identifier: NCT01767194

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United States, Arizona
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90242
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital Central California
Madera, California, United States, 93636-8762
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Children's Hospital of Orange County
Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
United States, Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
University of Florida
Gainesville, Florida, United States, 32610
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Florida Hospital Orlando
Orlando, Florida, United States, 32803
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Memorial University Medical Center
Savannah, Georgia, United States, 31404
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
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University of Illinois
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60611
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Oak Lawn, Illinois, United States, 60453
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Peoria, Illinois, United States, 61637
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Springfield, Illinois, United States, 62702
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Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
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Blank Children's Hospital
Des Moines, Iowa, United States, 50309
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
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University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
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Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
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Eastern Maine Medical Center
Bangor, Maine, United States, 04401
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
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C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Michigan State University Clinical Center
East Lansing, Michigan, United States, 48824-7016
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
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Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
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University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
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Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
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Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
Children's Specialty Center of Nevada II
Las Vegas, Nevada, United States, 89109
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
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Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Morristown Medical Center
Morristown, New Jersey, United States, 07960
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
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University of New Mexico
Albuquerque, New Mexico, United States, 87102
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Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Winthrop University Hospital
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11040
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
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Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
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Chapel Hill, North Carolina, United States, 27599
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Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
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Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
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Legacy Emanuel Children's Hospital
Portland, Oregon, United States, 97227
Oregon Health and Science University
Portland, Oregon, United States, 97239
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
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East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
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Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Lady Cilento Children's Hospital
South Brisbane, Queensland, Australia, 4101
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
New Zealand
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Christchurch Hospital
Christchurch, New Zealand, 8011
Puerto Rico
San Jorge Children's Hospital
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Rajen Mody Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01767194     History of Changes
Other Study ID Numbers: NCI-2012-03125, NCI-2012-03125, PANBL1221_A08PAMDREVW01, COG-ANBL1221, CDR0000745188, ANBL1221, ANBL1221, U10CA180886, U10CA098543
Study First Received: January 9, 2013
Last Updated: October 27, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 27, 2015