NCT00017147

S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Interventions

Type	Name	Description
DRUG	carmustine	40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG. 200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
RADIATION	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.
DRUG	O6-Benzylguanine	120 mg/m\^2 IV over 1 hour on day 1 of each cycle

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-05-01
• Completion: 2012-11-01
• First posted: 2003-01-27
• Last updated: 2013-01-30

Locations

163 sites across 1 country: United States