NCT00036894

CC-5013 in Treating Patients With Recurrent Glioma

A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent 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: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas. * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the antiangiogenic activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no). Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	lenalidomide

Timeline

• Start date: 2002-03-01
• First posted: 2003-01-27
• Last updated: 2015-04-30

Locations

1 site across 1 country: United States