Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Direct Therapeutics
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.)
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
