Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003176
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
- Detailed Description
OBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of recurrent glioblastomas to this combination. III. Estimate the response rate of newly diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV. Evaluate the qualitative and quantitative toxicities of this combination in patients with anaplastic gliomas.
OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may continue further at the investigator's discretion. Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed periodically at the investigator's discretion, at least twice in the first 4 months, and then until death.
PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States