CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|