Finding studies
Finding studies
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Lead
Pediatric Brain Tumor Consortium
With
OBJECTIVES: * Determine the dose of O(6)-benzylguanine that reliably inhibits alkylguanine-DNA alkyltransferase activity in pediatric patients with recurrent malignant glioma. * Describe the toxic effects of O(6)-benzylguanine with carmustine implant (Gliadel) in these patients. * Investigate antitumor response in patients treated with this regimen. * Characterize the pharmacokinetics of O(6)-benzylguanine when administered continuously over a 9-day period. OUTLINE: This is a multicenter, dose-escalation study of O(6)-benzylguanine. Patients receive O(6)-benzylguanine (O6-BG) IV over 1 hour immediately followed by O6-BG IV continuously for 9 days. Two days after initiation of continuous infusion of O6-BG, patients undergo maximal tumor debulking. At the time of surgery, patients receive up to 8 polifeprosan 20 wafers with carmustine (Gliadel) implanted into the resection cavity. Cohorts of up to 14 patients receive escalating doses of continuous infusion O6-BG until the optimally biologically effective dose (BED) is determined. The BED is defined as the dose at which at least 11 of 14 patients meet the target of complete suppression of alkylguanine-DNA alkyltransferase levels. Patients are followed at day 11, at weeks 2, 4, 6, 8, and 12, at months 6, 9, and 12, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
