Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Enzastaurin and Temozolomide in Patients With 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.
OBJECTIVES:
- 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.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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