Finding studies
Finding studies
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Lead
New Approaches to Brain Tumor Therapy Consortium
With
OBJECTIVES: * Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma. * Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine in this patient population. * Determine the pharmacokinetic profile of this regimen in these patients. * Estimate the efficacy of this regimen at the MTD in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13). Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose. Patients are followed at 6 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted