Interleukin-2 plus chemotherapy for patients with metastatic melanoma

We studied the activity of recombinant interleukin-2 (IL2) in combination with multiagent chemotherapy in the treatment of patients with disseminated malignant melanoma. Patients were randomized to receive the same dose of lymphokine by constant 24 h intravenous infusion (CI) or by subcutaneous bolus (SB) injection. Twenty-two patients, 18 males and four females with a median age of 44 years (range 32-73 years) were randomized to receive IL2 5 million units/m2 once daily by SB injection or by CI, 5 days/week for 2 weeks. All patients received a chemotherapy regimen consisting of lomustine (CCNU) 75 mg/m2 on day 14, bleomycin 10 units/day by CI for 5 days (days 14-19) and cisplatin 75 mg/m2 on day 19. Patients were retreated after a 3 week interval. There were four complete responses and one partial response in the CI arm and two partial responses in the SB arm. The median duration of response was 38 weeks (range 26-107 weeks). The median duration of survival was 6.7 months in non-responders and 11.1 months in responders. The overall response rate was 32%. Since responses were brief and all the responding patients progressed after a median of 38 weeks, the study was terminated before accrual goals were met.