Immunobiology of primary intracranial tumors. Part 7: Active immunization of patients with anaplastic human glioma cells: a pilot study.

Twenty patients with malignant gliomas were selected for active immunization within 4 weeks following surgery. Each patient had a Karnofsky Functional Rating equal to or greater than 70, a peripheral blood lymphocyte count equal to or greater than 1000 cells/cu mm, skin test responses to one or more of four recall antigens, peripheral blood T-cells equal to or greater than half that of control, and was not receiving steroid therapy at the time of entry into the study. Each patient received subcutaneous inoculations with one of two human glioma tissue culture cell lines (D-54MG or U-251MG) monthly, with 500 micrograms of bacillus Calmette-Guérin cell wall (BCG-CW) being included with the first inoculation. Each patient also received levamisole, 2.5 mg/kg 3 days per week every other week. Radiotherapy and chemotherapy with BCNU were begun after the first month of immunization. Follow-up evaluations included computerized tomography brain scans, neurological examinations, Karnofsky Functional Ratings, and studies of general immune competence. No evidence of allergic encephalomyelitis was noted clinically, nor was any gross or microscopic evidence of such pathology obtained upon autopsy of three of these patients. Serial studies of general immune competence showed no alterations from those previously described with non-immunized patients. Patients who were inoculated with the U-251MG cell line have had a longer survival time compared to those inoculated with the D-54MG cell line (p less than 0.0590) or compared to 58 historical cases of glioma patients treated with levamisole, radiation therapy, and chemotherapy alone (p less than 0.02).