CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
|ClinicalTrials.gov Identifier: NCT00074243|
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : April 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: CC-8490||Phase 1|
- 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.
- 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 (Clinical Trial)|
|Official Title:||A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas|
|Study Start Date :||December 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074243
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Howard A. Fine, MD||NCI - Neuro-Oncology Branch|