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.
Interventional
Primary Purpose: Treatment
Michael Prados, MD
Study Chair
UCSF Medical Center at Parnassus
United States: Federal Government
CDR0000065986
NCT00003176
January 1998
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |