Active specific immunotherapy for metastatic colorectal carcinoma: Phase Istudy of an allogeneic cell vaccine plus low-dose interleukin-1 alpha

A vaccine consisting of four allogeneic colon carcinoma cell lines (DLD-1, HCT116, WiDr, and T83) mixed with the adjuvant DETOX (Mycobacterium phlei c ell wall and Salmonella minnesota lipid A) was administered to 25 patients with low-volume metastatic colorectal carcinoma. The first eight patients r eceived vaccine only, given intradermally on three occasions at 3-week inte rvals. Subsequent patients also received subcutaneous interleukin-1 alpha ( IL-1 alpha), 0.3-0.5 mu g/m(2) per day for 8 days after each vaccination in an outpatient setting. Vaccine alone caused local erythema, induration, an d pruritus. IL-1 caused fevers, chills, and rigors that started in 4 h and lasted 1-2 h. One patient developed a brief loss of consciousness with a ri gor that resolved without sequelae. One episode of mild hypotension occurre d. Fatigue occurred by day 8 of IL-1. A substantial increase in the number of patients with positive skin tests to DLD-1 and HCT116 occurred after vac cine treatment both without and with IL-1 alpha. An allogeneic cell vaccine plus subcutaneous IL-1 was administered safely to outpatients with some ev idence of in vivo effect observed.