Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating
patients with anaplastic glioma.
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.
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