Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme
I. To estimate overall survival in newly diagnosed patients with glioblastoma multiforme
treated with R115777 before (and possibly after) radiation therapy.
I. To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme
treated with R115777 prior to therapy with radiation.
II. To estimate progression free survival in newly diagnosed patients with glioblastoma
multiforme treated with R115777 before (and possibly after) radiation therapy.
III. To describe the toxicity associated with this regimen in adult patients with newly
diagnosed glioblastoma multiforme.
OUTLINE: This is a multicenter study.
INDUCTION THERAPY: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment
repeats every 4 weeks for up to 3 courses.
RADIOTHERAPY: Within 14 days after the completion of induction therapy, patients undergo
radiotherapy daily, 5 days a week, for 6 weeks.
MAINTENANCE THERAPY: Two weeks after the completion of radiotherapy, patients receive
additional tipifarnib as in induction therapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
95% confidence intervals will be estimated.
Up to 5 years
New Approaches to Brain Tumor Therapy Consortium
United States: Food and Drug Administration
|New Approaches to Brain Tumor Therapy Consortium||Baltimore, Maryland 21231-1000|