Spots Global Cancer Trial Database for Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
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Trial Identification
Brief Title: Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
Official Title: A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
Study ID: NCT00003309
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use 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 more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.
Detailed Description: OBJECTIVES: * Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy. * Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation. * Determine the toxic effects associated with this treatment in these patients. OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Paul L. Moots, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
Name: Larry Kleinberg, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
Name: Geoffrey R. Barger, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: STUDY_CHAIR
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