PHASE-II STUDY OF COMBINED LEVAMISOLE WITH RECOMBINANT INTERLEUKIN-2 IN PATIENTS WITH ADVANCED MALIGNANT-MELANOMA

Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine-a ctivated killer cells (LAK) is an antineoplastic modality in which imm une-activated cells are administered to a host with advanced cancer in an attempt to mediate tumor regression. Levamisole (LEV), an immune s timulant, has been suggested to have therapeutic effectiveness in a va riety of cancers, After a phase I trial of recombinant IL-2 plus LEVI a phase II trial of this combination was conducted in patients with ad vanced malignant melanoma. Nineteen patients were entered in the trial . They received IL-2 at 3 x 10(6) U/m(2) subcutaneously daily x 5 plus LEV 50 mg/m(2) orally three times daily (p.o. t.i.d.) x 5. Patients w ere reevaluated at four-week intervals. None of the patients achieved a partial or complete regression (PR, CR). The median time to treatmen t failure (refusal, progression, or off study due to toxicity) was 56 days, Grade IV toxicities in eluded vomiting (3 patients), lethargy (1 patient), and musculoskellar pain (1 patient). This regimen is not re commended for further testing in patients with advanced malignant mela noma.