Phase II study of CC-5013 in patients (pts) with renal cell cancer (RCC)

4761 Background: Immunomodulatory drugs are a series of compounds that have originated via the deliberate structural modification of thalidomide. CC-5013 is a derivative with enhanced immunological and anti-angiogenic properties without the toxicity associated with the parent compound. Objectives were to determine response, rate time to progression, one-year survival, and toxicity in patients with stage IV RCC. Methods: Eligibility included measurable disease, normal organ/marrow function, Zubrod Performance Stauts ≤ 2, life expectancy ≥ 3 months, ≤ 1 prior therapy, and no active CNS disease. CC-5013 was administered orally at a dose of 25 mg per day for 21 days with 7 days rest (28-day cycle), with dose reductions for toxicity. Re-evaluation will be done every three cycles. Results: Twenty-two patients have enrolled into the first stage. Patient characteristics; 17 male, 5 female, age ranges 44 - 73 (median 62) years were included; 22 had histologic confirmed renal cell cancer. 12 patients had received p...