Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
- Determine the efficacy, as measured by 6-month progression-free survival, of a
dose-intense temozolomide treatment schedule in patients with recurrent high-grade
- Assess the toxicities of this dose-intense temozolomide.
- Determine the overall survival of patients treated with this dose-intense schedule.
- Determine whether methylation status of the MGMT gene within patients' tumors predicts
greater efficacy (progression-free survival), in patients treated on this protocol.
- Determine whether patients' tumors have functional alterations of the mismatch repair
(MMR) system by PCR analysis for microsatellite instability (MSI) and whether such
alterations may influence outcome in patients treated on this protocol.
- Determine how initial success with temozolomide may influence outcome in recurrent
patients treated on this protocol by evaluating patients progressing after two
first-line adjuvant courses of temozolomide, patients progressing within 6 months after
the 6th adjuvant course of temozolomide, and patients progressing 6 months after
temozolomide is voluntarily discontinued.
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment
repeats every 28 days for up to 12 courses in the absence of disease progression or
Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available
surgical samples are evaluated for molecular abnormalities in the tumor, including (but not
limited to) MGMT status and microsatellite instability.
After completion of study therapy, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma
multiforme [GBM]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy, as measured by 6-month progression-free survival, of the dose-intense temozolomide treatment schedule
Study start was 10.31.2007. Enrollment was completed on 12/22/2011
Nicholas A. Butowski, MD
University of California, San Francisco
United States: Data and Safety Monitoring Board
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|