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A phase I study of temozolomide (Temodar) and escalating doses of oral VP-16 for adults with recurrent malignant glioma The maximum tolerated dose of this combination in this heavily treated group of patients with recurrent malignant glioma is temozolomide 150 mg/m2/d for 5 days + oral VP-16 50 mg/m2/d for 12 days.

Posted on: 05/26/2002

A phase I study of temozolomide (Temodar) and escalating doses of oral VP-16 for adults with recurrent malignant glioma

David N Korones, Michal Benita-Weiss, Lazlo Mechtler, Peter Bushunow, Brandon L Evans, Henry S Friedman, University of Rochester School of Medicine, Rochester, NY; Dent Neurological Institute, Buffalo, NY; Duke University School of Medicine, Durham, NC.

Although temozolomide is active against recurrent malignant glioma, responses in many patients are modest and short-lived. temozolomide may prove more effective in combination with other agents, and combination oral chemotherapy for these patients is a particularly attractive approach. We conducted a phase 1 study of temozolomide in combination with escalating doses of oral VP-16 to determine the maximum tolerated doses of these 2 agents when given together. The temozolomide dose was fixed at 150 mg/m2/d days 1-5. The oral VP-16 was escalated in cohorts of 3 - 6 patients by numbers of days of VP-16 administered: 50 mg/m2/day, days 1-5 (dose level 1), days 1-8 (dose level 2), days 1-12 (dose level 3), days 1-16 (dose level 4) and days 1-20 (dose level 5). Therapy was given in 28 day cycles. Of the 29 patients enrolled, 26 were fully evaluable and 3 partially evaluable for toxicity The 29 patients received a total of 79 cycles. The median age of the patients was 49 years (range 28-76 years). Diagnoses include glioblastoma (19), gliosarcoma (3), anaplastic astrocytoma (5), and anaplastic oligoastrocytoma (2). The median time from diagnosis to recurrence was 8 months (3-188 mo.). Twenty patients were treated at first recurrence, 7 at second, and 2 at third recurrence. Twenty-four patients (83%) were on anti-convulsants, and 24 were on dexamethasone. All patients had received prior radiation and 25 of 29 had prior chemotherapy. Of the 3 patients at dose level 1, none had dose-limiting toxicity. Of the 6 patients at dose level 2, one patient had dose-limiting toxicity (DLT) - grade 3 thrombocytopenia resulting in a > 2 week delay in starting the next cycle of chemotherapy. Of the 6 patients at dose level 3, one patient had DLT– death due to Pneumocystis pneumonia. There were 2 DLT’s in the 7 patients at dose level 4 – death due to pneumonia, and fever, neutropenia, and Zoster. Of the 5 fully evaluable and 2 partially evaluable patients at dose level 5, there was no DLTc A phase II study of this combination is currently being conducted.

Source: ASCO 2002 Annual Conference
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