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.
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 Type
INTERVENTIONAL
Purpose
TREATMENT
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
NCI - Center for Cancer Research
Bethesda, Maryland, United States
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