A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM)
- Determine the maximum tolerated dose of arsenic trioxide when administered sequentially
with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma
- Determine the dose-limiting toxicities of this regimen in these patients.
OUTLINE: This is a dose-escalation study of arsenic trioxide.
Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also
receive arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7.
Treatment with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to
6 weeks in the absence of disease progression or unacceptable toxicity.
Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for
up to 12 courses in the absence of disease progression.
After completion of study therapy, patients are followed periodically.
Primary Purpose: Treatment
Maximum tolerated dose of arsenic trioxide
Jana Portnow, MD
Beckman Research Institute
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|