CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy

Phase 1

Completed

• Conditions: Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00031941
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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.

Study Timeline

• Study First Submitted: 2002-03-08
• Study Start: 2002-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-09
• Study Completion: 2009-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

NCI - Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States