Phase II Trial of Subcutaneous Interleukin-2, Subcutaneous Interferon-α, Intravenous Combination Chemotherapy, and Oral Tamoxifen in the Treatment of Metastatic Melanoma: Final Results of Cancer Biotherapy Research Group 94-11

Abstract

Background The treatment of metastatic melanoma remains unsatisfactory despite encouraging results with biotherapy and combination chemotherapy. Combining these two modalities may improve outcomes for such patients. Methods Eligible patients had metastatic melanoma, were in good medical condition, and had not been treated previously for metastatic disease. A 42-day treatment cycle consisted of: tamoxifen 10 mg p.o. b.i.d. days 1-42, carmustine 150mg/m2 i.v. on day three, dacarbazine 220 mg/m2 and cisplatin 25 mg/m2 i.v. q.d. days 3-5, and 24-26, interferon-α2b 6.0 MU/m2 s.c. days 8-12 and 29-33, and interleukin-211 MU/m2 s.c. days 8,10,12 and 29,31,33. In the absence of tumor progression, patients could receive up to six cycles of alternating treatment. Toxicity and tumor response was assessed following each treatment cycle; survival was determined from the first date of treatment. Results The 28 melanoma patients included 21 men and 7 women, with a median age of 55 years with a range of 26-77. Fifty-four...