Nonspecific immunotherapy by Corynebacterium parvum: phase I toxicity study in 12 patients with advanced cancer

Corynebacterium parvum, a non-specific immunopotentiator, was administered intravenously to 12 patients with advanced cancer at 2, 3, and 4 mg/m2 dose levels in combination with radiation therapy. One dose of C. parvum was given every 7 days for a total of 4 doses in 21 days. Symptoms and signs developed by these patients for a period of 3 to 6 hours during and shortly after the i.v. infusion of the first dose of C. parvum were moderately severe in nine patients and mild in three patients. For the second, third, and fourth doses of C. parvum, patients had fewer and less intense reactions and were given their treatments on an outpatient basis. There was no added morbidity to the patients' tolerance to either palliative or radical dose levels of radiation therapy. Changes in renal, hepatic, hematologic, and immunologic functions were minimal. At the above dose levels, the use of C. parvum to stimulate the reticuloendothelial system in humans by the intravenous route can be safe and well tolerated provided the side effects are appreciated and symptomatic treatments administered.