Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas
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.
;
Primary Purpose: Treatment
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