NCT00074243

CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	CC-8490

Timeline

• Start date: 2003-12-01
• First posted: 2003-12-11
• Last updated: 2015-04-30

Locations

1 site across 1 country: United States