A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are
progression-free at 6 months, time to progression, and time to death, in patients with
recurrent glioblastoma multiforme.
II. Determine the toxic effects of this drug in these patients. III. Correlate molecular
alterations in the tumors of these patients with response to treatment with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450
anticonvulsant use (yes vs no).
Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 5 years and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients being progression free
Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
North Central Cancer Treatment Group
United States: Food and Drug Administration
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