Clinical trial of corynebacterium parvum (intra‐lymph‐node and intravenous) and radiation therapy in the treatment of head and neck carcinoma

: Fifty-seven patients with previously untreated squamous cell carcinoma of the head and neck region of all clinical stages were entered a trial to evaluate the effectiveness of Corynebacterium parvum combined with radiation therapy in improving local and survival results. Twenty-nine patients were randomized to receive radiation therapy alone, and 28 patients were randomized to receive radiation therapy combined with C. parvum. The C. parvum was administered into the tumor-bearing lymph nodes of the neck or into the cervical node region in non-node-positive patients (4 mg/m2) and by intravenous routes (at 2, 2, 4, 4 and 4 mg/M2) at days -10, -7, and -3 before, and at +7 and +14 days after the start of radiation therapy. The study began in July 1975 and was terminated after 2 1/2 years of patient accession. The statistical analysis showed that those receiving C. parvum were not doing better than controls and, in fact, in some subgroups there was concern that they might be doing less well. Pertinently, analysis showed that those receiving C. parvum would not experience the 25% point improvement in disease-free survival frequency which had been stipulated in the design of the protocol.