We evaluated the method of active specific intralymphatic immunization to treat
cancer in 32 patients with various
tumor types as part of a broad-based phase I-II evaluation and describe the results of 3 sequential series. In series 1, the patients (n = 13) received 2 or more
injections of autologous, cryopreserved, irradiated
tumor cells directly into the lymphatic system through the cannulation of a dorsal pedal lymphatic channel. In series 2, the patients (n = 7) received low-dose
cyclophosphamide, 300 mg per m2, 3 days before the autologous cell
vaccine was administered. Series 3 (12 patients) was similar to series 2 except that the
tumor cells were treated with
cholesteryl hemisuccinate immediately before irradiation. Patients received from 2 to 6
injections of cells, depending on availability, at 2-week intervals. In all, 91 treatments are evaluated in this study. Clinical responses occurred in 7 of the 32 patients and were seen in all 3 series with about the same frequency. These responses occurred in cases of
melanoma,
lung cancer,
colon cancer, and
sarcoma. Regressions occurred in both visceral and subcutaneous sites. There was little toxicity, the chief side effect being local discomfort or
inflammation. This experience indicates that active specific intralymphatic
immunotherapy is safe, produces antitumor effects, and requires more investigation to increase the frequency and duration of observable
tumor regression.