A Cytokine Working Group phase II study of temozolomide (TMZ), thalidomide (THAL) and whole brain radiation therapy (WBRT) for patients with brain metastases from melanoma

7552 Background: The combination of TMZ and THAL was reported to produce a high response rate (RR) including shrinkage of CNS disease in patients (pts) with metastatic melanoma (Hwu et al JCO 21:3351). We tested the efficacy of a regimen involving TMZ/THAL and WBRT in pts with brain metastases from melanoma. Methods: Pts with melanoma and MRI documented brain metastases received WBRT, 30 Gy in 10 fractions days 1–5 and 8–12; TMZ 75mg/m2/day weeks 1–6; THAL 100 mg po/day weeks 1–4, then escalated by 100 mg/day at weeks 5, 7, and 9 as tolerated to a maximum of 400 mg/day. CNS and systemic tumor response was assessed at wk 10. Pts without CNS or clinically significant systemic progression received additional cycles of TMZ (same dose) and THAL (MTD from cycle 1) at 10 wk intervals. Pts with prior cytotoxic chemotherapy, WBRT or THAL were ineligible. Prior focused RT was permitted for oligometastatic CNS disease. Results: 40 pts (25 M/ 15 F), median age 49 (range 28–81), ECOG PS 0/1 (20/20) were enrolled in th...