Temozolomide in Treating Patients With Recurrent High-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT00619112|
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : October 29, 2013
Last Update Posted : January 31, 2018
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Central Nervous System Neoplasm||Drug: temozolomide||Phase 2|
- Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.
- 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 unacceptable toxicity.
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 this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||September 2012|
single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
single arm study
Other Name: temodar
- 6 Month Progression-free Survival [ Time Frame: First day of treatment until progression or until 6 months mark ]Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
- Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. [ Time Frame: First day of treatment until progression or until 6 months mark ]Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.
- Overall Survival [ Time Frame: up to 2 years after treatment ]
- Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System [ Time Frame: prior to start of study ]PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.
- Patients Progressing After Two First-line Adjuvant Courses of Temozolomide [ Time Frame: After two first-line adjuvant courses of temozolomide ]
- Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide [ Time Frame: Within 6 months after 6th adjuvant course of temozolomide ]
- Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued [ Time Frame: From beginning of voluntarily temozolomide discontinued up to 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619112
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Nicholas A. Butowski, MD||University of California, San Francisco|
|Principal Investigator:||Susan M. Chang, MD||University of California, San Francisco|