A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas

OBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of recurrent glioblastomas to this combination. III. Estimate the response rate of newly diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV. Evaluate the qualitative and quantitative toxicities of this combination in patients with anaplastic gliomas.

OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may continue further at the investigator's discretion. Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed periodically at the investigator's discretion, at least twice in the first 4 months, and then until death.

PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum.