RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.
OBJECTIVES: Primary * Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas. * Determine, preliminarily, the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine, preliminarily, the potential anti-glioma activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose. Patients are followed within 2 weeks. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
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