Phase II Trial of Combination Thalidomide plus Temozolomide in Patients with Metastatic Melanoma

Pts must have biopsy-proven diagnosis of malignant melanoma of cutaneous origin that is unresectable; Pts must have Stage IV disease; Pts with unknown primary are eligible; Pts must have measurable or non-measurable disease by CT, MRI PE or plain film; Pts may have received up to 1 (zero to one) prior systemic therapy (chemotherapy, biologic/immunotherapy, hormonal therapy or a combination regimen) excluding prior temozolomide, thalidomide or dacarbazine for Stage IV disease; Pts may have received prior alpha interferon in an adjuvant fashion; Prior brain mets are allowed, only if completely resected and had whole brain radiation; Prior RT is allowed, at least 28 days prior to registration and recovered from associated toxicities; Pts must have agreed to have blood submitted for immune testing at baseline, Weeks 5, 9 and 13 as outlined in Section 15.0; ANC >/= 1,000, PLTS >/= 100,000, Serum Bilirubin </= 3 x IULN, SGOT or SGPT </= 2.5 x IULN, unless liver is involved with tumor, then SGOT or SGPT must be </= 5 x IULN; Female pts of reproductive potential must have pregnancy test within 24 hours prior to the start of thalidomide; Pts must not be pregnant or nursing or of reproductive potential and not agreed to use effective contraceptive method; Pts must not have prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission and disease-free from ca for 5 yrs; Pts must have had surgery (for both primary and Stage IV disease) < 28 days prior to registration; Pts must be 18 yrs of age or older; Pts must have Zubrod PS 0-1; Serum Creatinine < 1.5 x IULN; Pts must have agreed to comply with the contraceptive guidelines of the thalidomide consent, patient warning letter and/or FDA-mandated S.T.E.P.S. program.