Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas
RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary
for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways
to stop tumor cells from dividing so they stop growing or die. Giving lonafarnib together
with temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lonafarnib when
given together with temozolomide in treating patients with recurrent primary supratentorial
glioma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when
administered with temozolomide in patients with recurrent primary supratentorial
gliomas.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the mechanism of action of lonafarnib in these patients.
- Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients.
- Determine the activity of this regimen in these patients.
- Determine the response to this regimen in patients who have measurable disease.
OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study of
lonafarnib.
Patients receive oral temozolomide once daily on days 2-6 of course 1 and on days 1-5 of all
subsequent courses. Patients also receive oral lonafarnib twice daily on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lonafarnib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experience
dose-limiting toxicity. An additional 3 patients may be treated at the highest dose level
achieved.
Patients are followed every 8 weeks for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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