Phase I and phase II studies in the treatment of cancer patients by radiotherapy, chemotherapy and methanol extraction residue of an anti tuberculosis vaccine (MER)

Immunotherapy by a methanol extraction residue (MER) of the tubercle bacilli was given to patients with malignant neoplasia. Two schedules of treatment were used: bi weekly or once a month administration of MER. Repeated injections were given to some patients. The skin reactivity to a battery of recall antigens, as well as to injected MER was used to monitor the immune response. Improvement of the skin reactivity occurred in 10 out of 26 patients tested with recall antigens. In 9 other patients skin reactivity remained intact. 5 out of 6 patients treated bi weekly, improved their immune response, while out of 20 patients on monthly schedule, 5 improved and 9 retained normal cutaneous reactivity. Thus, repeated and bi weekly injections were more effective in stimulating the immune response than few injections of MER. The few side effects were tolerable. In Phase II studies in lung cancer MER induced an improvement in the skin reaction and in the lymphocyte stimulation index. No prolongation of survival was found in the treated group as compared to the control.