Chemotherapy in Treating Patients With Recurrent Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients with recurrent primary malignant glioma.
Brain and Central Nervous System Tumors
Drug: topotecan hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)|
|Study Start Date:||February 1997|
|Study Completion Date:||May 2004|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of topotecan administered in combination with a fixed dose of carmustine.
- Determine the toxic effects of topotecan and carmustine in patients with recurrent primary malignant glioma.
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week. Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is continued until toxic effects or disease progression is observed in these patients. Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of 6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002986
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Tennessee|
|Saint Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|