ACTIVE IMMUNOTHERAPY WITH ULTRAVIOLET B-IRRADIATED AUTOLOGOUS WHOLE MELANOMA-CELLS PLUS DETOX IN PATIENTS WITH METASTATIC MELANOMA

Our objective was to determine the clinical activity, toxicity, and im munological effects of active immunotherapy using UVB-irradiated (UVR) autologous tumor (AT) cells plus adjuvant DETOX in metastatic melanom a patients, Eligibility included nonanergic patients fully recovered a fter resection of 5 or more grams of metastatic melanoma, Treatment co nsisted of intradermal injections of 10(7) UVR-AT plus 0.25 ml of DETO X every 2 weeks x 6, then monthly, Peripheral blood mononuclear cells (PBMCs) were harvested for cytotoxicity assays, and skin testing was p erformed for delayed-type hypersensitivity (DTH) determinations before the first, fourth, seventh, and subsequent treatments, Forty-two pati ents were treated, 18 in the adjuvant setting and 24 with measurable d isease, Among the latter group, there were two durable responses in so ft-tissue sites and in a bone metastasis. Treatment was well tolerated , Thirty-five patients were assessable for immunological parameters; 1 0 of these patients, including the 2 responders, demonstrated early in duction of PBMC cytotoxicity against AT cells that persisted up to 10 months on treatment before falling to background levels, In five of se ven patients, the fall-off heralded progressive disease, Late inductio n of a weak DTH reaction to AT cells was observed in eight patients, A ctive immunotherapy with UVR-AT + DETOX had modest but definite clinic al activity in advanced melanoma, The induction of both PBMC cytotoxic ity and DTH reactivity to AT cells supported a specific systemic immun e effect of treatment, although the former more closely followed disea se course in this study.