Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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. Giving enzastaurin together with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when given together with temozolomide in treating patients with primary gliomas.
Brain and Central Nervous System Tumors
Drug: enzastaurin hydrochloride
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas|
- Recommended phase II dose [ Designated as safety issue: Yes ]
- Dose-limiting toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Pharmacokinetics of enzastaurin hydrochloride alone and in combination with temozolomide [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
- To assess if full doses of enzastaurin hydrochloride and temozolomide can be used in combination for the treatment of patients with primary gliomas.
- To determine the recommended phase II dose.
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28* and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: *During the first course only, patients also receive enzastaurin hydrochloride on day -1.
Patients undergo blood sample collection on day 22 of course 1 and on day 5 of course 2 for pharmacokinetic studies of enzastaurin hydrochloride.
After completion of study treatment, patients are followed within 30 days and then every 3 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516607
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Study Chair:||Roy Rampling, MD, PhD||University of Glasgow|