S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
- Conditions
- Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
- Interventions
- Registration Number
- NCT00017147
- Lead Sponsor
- SWOG Cancer Research Network
- 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. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.
- Detailed Description
OBJECTIVES:
* Compare the overall survival, failure-free survival, and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine.
* Compare the frequency and severity of toxic effects of these regimens in these patients.
* Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 50 vs 50 and over), prior surgery (biopsy only vs resection), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions. Patients also receive chemotherapy comprising O6-benzylguanine IV over 1 hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy. Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV as in arm I.
Patients are followed at week 48, every 4 months for 1 year, and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description O6-BG + BCNU + Radiation Therapy radiation therapy O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. BCNU + Radiation Therapy radiation therapy BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. O6-BG + BCNU + Radiation Therapy carmustine O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. O6-BG + BCNU + Radiation Therapy O6-Benzylguanine O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. BCNU + Radiation Therapy carmustine BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
- Primary Outcome Measures
Name Time Method Survival assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
- Secondary Outcome Measures
Name Time Method Time to treatment failure assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5 Progression-free survival assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5 Toxicity assessed weekly for 42 weeks
Trial Locations
- Locations (163)
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Banner Thunderbird Medical Center
🇺🇸Phoenix, Arizona, United States
North Bay Cancer Center
🇺🇸Fairfield, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Scroll for more (153 remaining)Alaska Regional Hospital Cancer Center🇺🇸Anchorage, Alaska, United States