A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas

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.