Neuroblastoma Clinical Trial
Official title:
An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors
Verified date | August 2013 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and vincristine, work in
different ways to stop tumor cells from dividing so they stop growing or die. Radiation
therapy uses high-energy x-rays to damage tumor cells. Combining carboplatin and vincristine
with radiation therapy followed by adjuvant chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy
plus radiation therapy followed adjuvant chemotherapy in treating young patients who have
newly diagnosed high-risk CNS embryonal tumors.
Status | Completed |
Enrollment | 168 |
Est. completion date | March 2012 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven high-risk CNS embryonal tumors, including: - Primitive neuroectodermal tumors - Atypical teratoid/rhabdoid tumor - Medulloblastoma - Desmoplastic medulloblastoma - Ependymoblastoma - Medullomyoblastoma - Spongioblastoma - Spongioblastoma polare - Primitive polar spongioblastoma - Neuroepitheliomatous neoplasms - Medulloepithelioma - Neuroblastoma - Pineoblastoma - No bone marrow involvement or bone metastases - No M4 disease - M3 disease must have evidence of tumor on spinal MRI PATIENT CHARACTERISTICS: Age: - 3 to 21 at diagnosis Performance status: - Not specified Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed) Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT/SGPT less than 2.5 times normal Renal: - Creatinine less than 1.5 times upper limit of normal OR - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Prior definitive surgery allowed |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | IWK Grace Health Centre | Halifax | Nova Scotia |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Children's Hospital of Columbus | Columbus | Ohio |
United States | Children's Hospital of Denver | Denver | Colorado |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | Long Beach Memorial Medical Center | Long Beach | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | University of Minnesota Cancer Center | Minneapolis | Minnesota |
United States | Vanderbilt Cancer Center | Nashville | Tennessee |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Doernbecher Children's Hospital | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | UCSF Cancer Center and Cancer Research Institute | San Francisco | California |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada,
Jakacki R, Burger P, Zhou T, et al.: Outcome for metastatic (M+) medulloblastoma (MB) treated with carboplatin during craniospinal radiotherapy (CSRT) followed by cyclophosphamide (CPM) and vincristine (VCR): preliminary results of COG 99701. [Abstract] J
Jakacki RI, Burger PC, Zhou T, Holmes EJ, Kocak M, Onar A, Goldwein J, Mehta M, Packer RJ, Tarbell N, Fitz C, Vezina G, Hilden J, Pollack IF. Outcome of children with metastatic medulloblastoma treated with carboplatin during craniospinal radiotherapy: a — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event Free Survival | Minimum time to disease progression or recurrence, time to death for any reason, or time to occurrence of a second malignant neoplasm (SMN). | Length of study | Yes |
Secondary | Survival | Time to death from any cause | Length of study | Yes |
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