title: Active specific immunotherapy for metastatic colorectal carcinoma: phase I study of an allogeneic cell vaccine plus low-dose interleukin-1 alpha.
abstract: A vaccine consisting of four allogeneic colon carcinoma cell lines (DLD-1, HCT116, WiDr, and T84) mixed with the adjuvant DETOX (Mycobacterium phlei cell wall and Salmonella minnesota lipid A) was administered to 25 patients with low-volume metastatic colorectal carcinoma. The first eight patients received vaccine only, given intradermally on three occasions at 3-week intervals. Subsequent patients also received subcutaneous interleukin-1 alpha (IL-1 alpha), 0.3-0.5 microgram/m2 per day for 8 days after each vaccination in an outpatient setting. Vaccine alone caused local erythema, induration, and 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 rigor that resolved without sequelae. One episode of mild hypotension occurred. 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 vaccine treatment both without and with IL-1 alpha. An allogeneic cell vaccine plus subcutaneous IL-1 was administered safely to outpatients with some evidence of in vivo effect observed.
authors.affiliation: Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
authors.forename: T J
authors.initials: TJ
authors.lastname: Woodlock
authors.forename: D M
authors.initials: DM
authors.lastname: Sahasrabudhe
authors.forename: D M
authors.initials: DM
authors.lastname: Marquis
authors.forename: D
authors.initials: D
authors.lastname: Greene
authors.forename: K J
authors.initials: KJ
authors.lastname: Pandya
authors.forename: C S
authors.initials: CS
authors.lastname: McCune
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000276:immunology / Q000628:therapy*; D005260:Female; D006510:Hepatitis B Antibodies / Q000097:blood; D006801:Humans; D016233:Immunotherapy, Active; D007375:Interleukin-1 / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008050:Lipid A / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology; D009362:Neoplasm Metastasis; D012004:Rectal Neoplasms / Q000276:immunology / Q000628:therapy*; D012882:Skin Tests; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D019496:Cancer Vaccines; D006510:Hepatitis B Antibodies; D007375:Interleukin-1; D008050:Lipid A