Lymphoma Clinical Trial
Official title:
A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer
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.
;
Primary Purpose: Treatment
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