CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer|
|Study Start Date:||April 2002|
|Study Completion Date:||April 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors and/or lymphoma.
- Characterize the pharmacokinetic profile of this drug in these patients.
- Determine whether any correlations can be made between plasma concentrations of this drug and toxicity or clinical activity or biological activity in these patients.
- Characterize the side effect profile of this drug in these patients.
- Determine the dose-limiting toxicity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days 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 total of 3-51 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031941
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||William Dahut, MD||NCI - Medical Oncology Branch|