A phase II trial of DTIC with thalidomide (thal) in metastatic melanoma (MM)

7543 Background: Single agent DTIC has a response rate of 10–20% in metastatic melanoma. In an attempt to improve disease response, thalidomide was added to standard dose DTIC in patients with MM. Methods: Eligibility: Stage IV MM, ECOG performance status 0–1, no prior chemotherapy, no brain mets and adequate hematologic and organ function. Patients received DTIC 1000 mg/m2 IV every 3 weeks with thal 200 mg daily at night (hs). Thal doses were escalated in 100 mg increments every 3 weeks as tolerated. Responses were assessed after 3 cycles. Results: 15 patients were accrued between 6/00 and 7/03 (IV1a-2, IV1b-7, IV1c-6). 6 patients had prior adjuvant vaccine or immunotherapy and 9 had no prior adjuvant therapy. LDH was elevated in 8/15. Ages ranged from 30–77. M:F=8:7. Thal doses ranged from 200–400 mg/d. The median tolerated dose of thal was 200 mg/d. Patients received 1–18 cycles of therapy (median = 5). Responses were as follows: complete-0, partial-1( in subcutaneuos tissue), stable-4, progression-5 w...