Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who
have progressive or recurrent glioblastoma multiforme.
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in
patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study
closed to accrual as of 01/15/2002.)
- Determine the qualitative and quantitative toxicity of this regimen in these patients.
- Assess the activity of this regimen in these patients.
- Estimate peripheral blood carmustine levels in these patients treated with this
regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during
stereotactic biopsy or open craniotomy.
Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose-limiting toxicity. (Phase I of this study closed to accrual as of
01/15/2002.)
Additional patients then receive treatment with DTI-015 at the recommended phase II dose.
Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease
progression.
PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and
approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this
study closed to accrual as of 01/15/2002.)
;
Primary Purpose: Treatment
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