This is a Phase I study of a human monoclonal antibody to the CD3 antigen, an antigen that is associated with the T-cell receptor. We examined patients for evidence of tumor response to monoclonal antibody treatment and also for immunomodulatory properties of the antibody. Anti-CD3 was to be given in a dose escalation manner with six groups of three patients each being treated with increasing doses. Only three patients have been treated on this protocol and each patient received 1 microgram of anti-CD3. Two patients did not have any toxicity, whereas one patient had treatment discontinued after four doses because of a severe bifrontal headache. None of the patients had a tumor response during monoclonal antibody treatment. There were no significant immunological changes noted in the patients' peripheral blood during treatment.
