Phase II Trial of Velcade (Bortezomib) in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme
- Estimate the overall survival at 2 years of patients with newly diagnosed glioblastoma
multiforme treated with bortezomib in combination with temozolomide and regional
radiotherapy followed by maintenance therapy comprising bortezomib and temozolomide.
- Investigate further the safety and tolerability of this regimen in these patients.
- Determine the molecular characterization of tumor tissue and correlate these findings
OUTLINE: This is a multicenter study.
- Adjuvant chemotherapy: Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36,
and 39 and oral temozolomide on days 1-42. Patients undergo external-beam fractionated
regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression
or unacceptable toxicity.
- Maintenance: Beginning 2-6 weeks after radiotherapy, patients receive bortezomib IV on
days 1, 4, 8, and 11 and oral temozolomide on days 1-5. Treatment repeats every 28 days
for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline (from surgery) and periodically during study
for further analysis.
After completion of study therapy, patients are followed up periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Albert Lai, MD, PhD
Ronald Reagan UCLA Medical Center
United States: Food and Drug Administration
|University of California Los Angeles||Los Angeles, California 90095-6951|