This protocol is a phase II trial with primary goals to examine the efficacy and toxicity of DTIC in the treatment of patients with recurrent glioma and to describe the pharmacokinetics of DTIC, MTIC, and hydroxymethyl MTIC in Mayo Clinic patients treated on this study. The protocol has accrued a total of 39 patients (13 from Mayo) and is temporarily closed because it met its original accrual objectives. An abstract describing the complete pharmacokinetic data was presented at the American Association of Cancer Research in 1998. We were able to determine that a dose of 200 mg/m2/day for five consecutive days produced prolonged exposure to MTIC and HMMTIC compared to the single dose schedule at 750 mg/m2. In addition, we noted transient intravascular hemolysis associated with hemoglobinuria in patients treated on the higher dose arm. Neither the pharmacokinetics nor this toxicity had been reported previously. We will complete the review of neuroimaging studies done outside of Mayo Clinic. If there is evidence of tumor regression, the study will be reopened to additional patients per protocol. If there is no evidence of tumor improvement, the study will be permanently closed.
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