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Abstract
Preclinical data suggest that one method of inducing autoimmunity to tumor is the administration and subsequent withdrawal of cyclosporine A following chemotherapy and that this effect may be enhanced with interferon and interleukin-2. Consequently, we performed a phase II trial in patients with advanced melanoma to explore this approach. Thirty-three patients were treated with BCNU (150 mg/m2 iv every 8 weeks), cisplatin (25 mg/m2 iv days 1–3) every 4 weeks, DTIC (220 mg/m2 iv days 1–3 every 4 weeks) along with tamoxifen (10 mg po BID days 1–4). Cyclosporine A at 3 mg/kg/day in two divided doses was given on days 4–21, alpha-interferon 1 million units/m2 subcutaneously every other day on days 4–21 and interleukin-2 1 million units/m2 BID subcutaneously days 21–28 were also given. Of the 33 patients, 3 patients (9%) had complete response and 8 patients (24%) had a partial response for a total response rate of 33% (95% confidence interval 18–52%). Median duration of response was 17 months (range 3 + to 24 + months). Six patients continue to show no signs of tumor progression for 3 +, 5 +, 10 +, 24 +, 60 +, and 72 + months. Toxicity was generally well tolerated and included myelosuppression and fatigue. This regimen is feasible and generally tolerable and has produced an antitumor response rate comparable with inpatient biochemotherapy regimens.