PHASE 1 EVALUATION OF INTRATUMORAL INTERLEUKIN-1 ALPHA

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The purpose of this protocol is to determine the maximum tolerated dose (MTD) of intralesional interleukin-I (IL-1) alpha. We plan to examine tumor specimens obtained before and after intralesional injection of IL-1 using immunohistochemical techniques. The tumor response in the injected lesion and in distant metastases will be monitored. A dose escalation scheme with half-log increments will be used to determine the MTD. The starting dose was 0.001 mu-g/kg; patients are currently being treated at the 0.1 mu-g/kg dose level. The MTD has not been determined to date. Patients treated with intralesional IL-1 alpha experienced similar toxicities to those observed with intravenous IL-1 alpha. Biopsy specimens of lesions injected with IL-1 show evidence of vasculitis with lymphoid aggregates surrounding vessels outside the injected tumor nodule and occasionally vessels within the tumor itself. Tumor biopsies have shown evidence of intratumoral lymphoid aggregates that were not identified on pretherapy biopsy specimens. Neither local nor systemic antitumor responses have occurred in this initial group of 15 patients.