Trials / Completed
CompletedNCT00031941
CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Institutes of Health Clinical Center (CC) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: * 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | lenalidomide |
Timeline
- Start date
- 2002-04-01
- Primary completion
- 2007-09-01
- Completion
- 2009-04-01
- First posted
- 2003-01-27
- Last updated
- 2012-03-15
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00031941. Inclusion in this directory is not an endorsement.