Pseudomonas vaccine: A phase I evaluation for cancer research

Abstract

A heptavalent lipopolysaccharide vaccine of Pseudomonas aeruginosa (Pseudogen) was administered at four dose levels (0.1, 0.25, 0.5, and 0.75 mg/m2) to patients with advanced metastatic cancer that had proved refractory to chemotherapy. The vaccine was administered subcutaneously twice weekly. Local toxicity was seen in erythema, edema, pain and tenderness at the site of injection, and painful regional lymphadenopathy; manifestations of systemic toxicity included fever, chills, myalgias, nausea, and vomiting. Toxicity showed a clear-cut dose dependence. The maximally tolerated dose by this route and schedule was 0.5 mg/m2. A significant rise of antibody titers was observed at all four dose l..