Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Children's Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00392327
First received: October 25, 2006
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Condition Intervention Phase
Untreated Childhood Medulloblastoma
Untreated Childhood Pineoblastoma
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
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: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival (EFS) percentage [ Time Frame: Time from disease progression or recurrence, occurrence of a second malignant neoplasm, or death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
    Based on stratified logrank test, with stratification on all randomization stratifiers as well as on the factorial treatment group not the subject of the analysis.


Secondary Outcome Measures:
  • Tumor response to radiation therapy with or without carboplatin [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Using a two-sided test of proportions with type I error 5%, this sample size will provide at least 80% power to detect a 30% difference in post-radiation therapy response rate between the two treatment groups.

  • Time to death [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Survival percentage will be computed from time to death.


Estimated Enrollment: 400
Study Start Date: March 2007
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (chemoradiotherapy)

CHEMORADIOTHERAPY: Patients undergo radiation therapy QD five days a week for 6 weeks. Patients also receive vincristine sulfate IV over 1 minute once weekly for 6 weeks. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive cisplatin IV over 6 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim SC or IV beginning on day 4 and continuing until blood counts recover (at least 10 days).

Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm II (chemoradiotherapy)

CHEMORADIOTHERAPY: Patients receive vincristine sulfate and undergo radiation therapy as in Arm I. Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm I.

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Carboplatin
Given IV
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm III (chemoradiotherapy, isotretinoin)

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive isotretinoin PO BID on day 1 and days 16-28 and cisplatin, vincristine sulfate, cyclophosphamide, and filgrastim as in Arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Drug: Isotretinoin
Given PO
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Experimental: Arm IV (chemoradiotherapy, isotretinoin)

CHEMORADIOTHERAPY: Patients undergo chemoradiotherapy as in Arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.

MAINTENANCE THERAPY: Patients receive maintenance therapy as in Arm III. Patients then proceed to continuation therapy.

CONTINUATION THERAPY: Patients receive continuation therapy as in Arm III.

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT
Drug: Vincristine Sulfate
Given IV
Other Names:
  • Kyocristine
  • Oncovin
  • VCR
  • Vincasar
Drug: Carboplatin
Given IV
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Drug: Isotretinoin
Given PO
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor

    • As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued
    • All patients with M4 disease are not eligible
  • A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility

    • Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory
    • Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred
  • Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively
  • Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks
  • No previous chemotherapy or radiation therapy
  • Patients taking Accutane (isotretinoin) for acne must discontinue drug use with this indication prior to enrollment; corticosteroids should not be used during chemotherapy administration as an antiemetic

    • Isotretinoin is contraindicated in patients with parabens allergy and patients with soybean allergy; concurrent use with tetracyclines should be avoided; intake of vitamin A should be limited for the duration of isotretinoin treatment
  • Selected strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (cytochrome P450 3A4) include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort; the use of these drugs should be avoided with vincristine (vincristine sulfate)
  • CYP450 3A4 stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
  • Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity

    • Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
  • No other experimental therapy is permitted while on study
  • 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:

    • 0.4 mg/dL (1 month to < 6 months of age)
    • 0.5 mg/dL (6 months to < 1 year of age)
    • 0.6 mg/dL (1 to < 2 years of age)
    • 0.8 mg/dL (2 to < 6 years of age)
    • 1.0 mg/dL (6 to < 10 years of age)
    • 1.2 mg/dL (10 to < 13 years of age)
    • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
  • Total bilirubin < 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age; for patients on anti-seizure medications, SGOT (AST) or SGPT (ALT) must be < 5 x ULN
  • Absolute neutrophil count (ANC) >= 1,000/uL
  • Platelets >= 100,000/uL (untransfused)
  • Hemoglobin >= 8 g/dl (may be transfused)
  • Female patients who are post-menarchal must have a negative pregnancy test; lactating female patients must agree not to breast-feed while on this trial; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  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: NCT00392327

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Active, not recruiting
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Withdrawn
Birmingham, Alabama, United States, 35233
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
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 Active, not recruiting
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
Children's Hospital Central California Active, not recruiting
Madera, California, United States, 93636-8762
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 Active, not recruiting
Palo Alto, California, United States, 94304
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
University of California San Francisco Medical Center-Parnassus Withdrawn
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Active, not recruiting
San Francisco, California, United States, 94158
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 Active, not recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
Lombardi Comprehensive Cancer Center at Georgetown University Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
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
Memorial Healthcare System - Joe DiMaggio Children's Hospital Active, not recruiting
Hollywood, Florida, United States, 33021
Nemours Children's Clinic-Jacksonville South Active, not recruiting
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine-Sylvester Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Miami Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
Arnold Palmer Hospital for Children Active, not recruiting
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Active, not recruiting
Orlando, Florida, United States, 32827
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 Children's Hospital of Tampa Active, not recruiting
Tampa, Florida, United States, 33607
Saint Mary's Hospital Active, not recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta - Egleston Active, not recruiting
Atlanta, Georgia, United States, 30322
Memorial University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31404
United States, Hawaii
University of Hawaii Cancer Center Withdrawn
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Active, not recruiting
Honolulu, Hawaii, United States, 96826
United States, Idaho
Saint Luke's Mountain States Tumor Institute Active, not recruiting
Boise, Idaho, United States, 83712
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 Active, not recruiting
Chicago, Illinois, United States, 60637
Loyola University Medical Center Active, not recruiting
Maywood, Illinois, United States, 60153
Advocate Children's Hospital-Oak Lawn Active, not recruiting
Oak Lawn, Illinois, United States, 60453
Advocate Children's Hospital-Park Ridge Active, not recruiting
Park Ridge, Illinois, United States, 60068
Advocate Lutheran General Hospital. Withdrawn
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Active, not recruiting
Peoria, Illinois, United States, 61602
Southern Illinois University Active, not recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Riley Hospital for Children Active, not recruiting
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Services Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital Active, not recruiting
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics Active, not recruiting
Iowa City, Iowa, United States, 52242
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
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans Active, not recruiting
New Orleans, Louisiana, United States, 70118
United States, Maine
Eastern Maine Medical Center Active, not recruiting
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland/Greenebaum Cancer Center Withdrawn
Baltimore, Maryland, United States, 21201
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21287
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
United States, Massachusetts
Floating Hospital for Children at Tufts Medical Center Withdrawn
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02115
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
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center Active, not recruiting
Detroit, Michigan, United States, 48236
Michigan State University Clinical Center Active, not recruiting
East Lansing, Michigan, United States, 48824-7016
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
Kalamazoo Center for Medical Studies Recruiting
Kalamazoo, Michigan, United States, 49008
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Active, not recruiting
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview Active, not recruiting
Minneapolis, Minnesota, United States, 55455
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
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
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Children's Hospital and Medical Center of Omaha Active, not recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Research Foundation CCOP Active, not recruiting
Las Vegas, Nevada, United States, 89106
Children's Specialty Center of Nevada II Active, not recruiting
Las Vegas, Nevada, United States, 89109
Sunrise Hospital and Medical Center Active, not recruiting
Las Vegas, Nevada, United States, 89109
Summerlin Hospital Medical Center Active, not recruiting
Las Vegas, Nevada, United States, 89144
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
Saint Barnabas Medical Center Terminated
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Active, not recruiting
Morristown, New Jersey, United States, 07962
Saint Peter's University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08901
UMDNJ - Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Active, not recruiting
Paterson, New Jersey, United States, 07503
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 Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
University of New Mexico Suspended
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center Active, not recruiting
Albany, New York, United States, 12208
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 Active, not recruiting
Mineola, New York, United States, 11501
The Steven and Alexandra Cohen Children's Medical Center of New York Active, not recruiting
New Hyde Park, New York, United States, 11040
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Mount Sinai Medical Center Active, not recruiting
New York, New York, United States, 10029
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter G. Steinherz    212-639-7202      
Principal Investigator: Peter G. Steinherz         
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University Active, not recruiting
Syracuse, New York, United States, 13210
New York Medical College Withdrawn
Valhalla, New York, United States, 10595
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center 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 Withdrawn
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 Active, not recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Active, not recruiting
Columbus, Ohio, United States, 43205
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 Active, not recruiting
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 Active, not recruiting
Danville, Pennsylvania, United States, 17822
Penn State Hershey Children's Hospital Active, not recruiting
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Saint Christopher's Hospital for Children Active, not recruiting
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15224
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: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
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
Vanderbilt-Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Tech University Health Science Center-Amarillo Withdrawn
Amarillo, Texas, United States, 79106
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
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
Covenant Children's Hospital Active, not recruiting
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas Active, not recruiting
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital Active, not recruiting
Temple, Texas, United States, 76508
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 Active, not recruiting
Burlington, Vermont, United States, 05405
United States, Virginia
Inova Fairfax Hospital Active, not recruiting
Falls Church, Virginia, United States, 22042
Childrens Hospital-King's Daughters Active, not recruiting
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University/Massey Cancer Center Active, not recruiting
Richmond, Virginia, United States, 23298
Carilion Clinic Children's Hospital Active, not recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Seattle Children's Hospital Active, not recruiting
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital Active, not recruiting
Spokane, Washington, United States, 99204
Mary Bridge Children's Hospital and Health Center Active, not recruiting
Tacoma, Washington, United States, 98405
Madigan Army Medical Center Active, not recruiting
Tacoma, Washington, United States, 98431
United States, West Virginia
West Virginia University Charleston Active, not recruiting
Charleston, West Virginia, United States, 25304
West Virginia University Healthcare Active, not recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301
Marshfield Clinic Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Women's and Children's Hospital-Adelaide Active, not recruiting
North Adelaide, South Australia, Australia, 5006
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Canada, Alberta
University of Alberta Hospital Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Active, not recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Chedoke-McMaster Hospitals Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
The Montreal Children's Hospital of the MUHC Withdrawn
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Quebec Active, not recruiting
Ste-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Saskatoon Cancer Centre Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Netherlands
Dutch Childhood Oncology Group Active, not recruiting
Den Haag, Netherlands, 2504 AM
Puerto Rico
San Jorge Children's Hospital Withdrawn
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Olson, MD, PhD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00392327     History of Changes
Other Study ID Numbers: ACNS0332  NCI-2009-00336  COG-ACNS0332  CDR0000511991  ACNS0332  ACNS0332  R01CA114567  U10CA180886  U10CA098543 
Study First Received: October 25, 2006
Last Updated: August 19, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Medulloblastoma
Carboplatin
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Pinealoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Glioma
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cisplatin
Cyclophosphamide
Vincristine
Lenograstim
Isotretinoin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on December 07, 2016