ACTIVE INTRALYMPHATIC IMMUNOTHERAPY OF UTERINE CERVICAL-CARCINOMA WITH VIRAL ONCOLYSATE - A PILOT-STUDY

A pilot clinical trial was conducted in patients with squamous carcino ma of the uterine cervix to evaluate the clinical and biologic effects of active intralymphatic immunotherapy (AILI) with allogenic viral on colysate (VO) prior to radiation therapy. Sixteen patients with advanc ed primary squamous carcinoma of the uterine cervix and lymph node met astases underwent bipedal intralymphatic injections of VO. VO was deri ved from lysates of cervical carcinoma cells that had been infected wi th influenza A virus. AILI was repeated after 2 weeks and followed one week later by standard or extended-field radiation therapy (RT). The first seven patients were treated at one of the three dose levels: 6 m g (three patients), 12 mg (three patients) and 18 mg (one patient). Re maining patients were treated at the 12 mg dose level. Sixteen patient s received 63 injections (one patient received three of four doses) of AILI-VO without significant toxicity. Eleven patients have died of pe rsistent or recurrent carcinoma with a total median survival of 19.4 m onths. Examination of humoral and cellular immunity during AILI-VO sho wed an increase in the serum titers of antibodies to a surface antigen on cervical carcinoma cells and to the influenza virus. Increased non -MHC restricted lymphocyte cytotoxicity was exhibited by three of four patients treated above the first dose level. Two of the three patient s are survivors. By contrast, lymphocytes of patients treated with AIL I-VO exhibited either an increase or a decrease in proliferation respo nses to cervical carcinoma cells. Similarly, post-treatment lymphocyte s exhibited either helper or suppressor inducer effects on pre-treatme nt lymphocytes.