Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00392327 |
|
Recruitment Status
:
Recruiting
First Posted
: October 26, 2006
Last Update Posted
: August 31, 2017
|
Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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 or disease | Intervention/treatment | 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 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2007 |
| Estimated Primary Completion Date : | June 2018 |
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources:
Medulloblastoma
Neuroepithelioma
Pineoblastoma
Medulloblastoma, Childhood
Supratentorial Primitive Neuroectodermal Tumor
Supratentorial Primitive Neuroectodermal Tumors, Childhood
Pineoblastoma, Childhood
Pineocytoma
Glioma
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
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:
Drug: Vincristine Sulfate
Given IV
Other Names:
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
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:
Drug: Vincristine Sulfate
Given IV
Other Names:
Drug: Carboplatin
Given IV
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
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:
Drug: Vincristine Sulfate
Given IV
Other Names:
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
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:
Drug: Vincristine Sulfate
Given IV
Other Names:
Drug: Carboplatin
Given IV
Drug: Cisplatin
Given IV
Drug: Cyclophosphamide
Given IV
Biological: Filgrastim
Given IV or SC
Other Names:
Drug: Isotretinoin
Given PO
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
|
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 ]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 ]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 ]Survival percentage will be computed from time to death.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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
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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
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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
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Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, D.C., District of Columbia, United States, 20010 | |
| Lombardi Comprehensive Cancer Center at Georgetown University | Active, not recruiting |
| Washington, D.C., 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 | |
| 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 | |
| Montefiore Medical Center - Moses Campus | Active, not recruiting |
| The Bronx, New York, United States, 10467-2490 | |
| 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 |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00392327 History of Changes |
| Other Study ID Numbers: |
ACNS0332 NCI-2009-00336 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ACNS0332 ( Other Identifier: Children's Oncology Group ) CDR0000511991 ( Other Identifier: ClinicalTrials.gov ) ACNS0332 ( Other Identifier: Children's Oncology Group ) ACNS0332 ( Other Identifier: CTEP ) R01CA114567 ( U.S. NIH Grant/Contract ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 26, 2006 Key Record Dates |
| Last Update Posted: | August 31, 2017 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
|
Medulloblastoma Carboplatin Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Pinealoma Glioma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue 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 |