Table 2

Vaccine trial composition and distinctions

Phase I APhase I BPhase II
Vaccine7 patients3 patients2 patients
Vaccine + chemotherapy1 patient2 patients10 patients
Antigen sourceTumor line MHC I-elutionTumor lysateTumor lysate
Vaccine course3; 2 wks apart3; 2 wks apart3; 2 wks apart + 1; 6 wks later
 DiagnosisNewly diagnosed GBM, newly diagnosed AARecurrent GBM, AANewly diagnosed or recurrent GBM, AA
 Karnofsky score>60>60>60
 Age (yrs)>18>18>18
Vaccine responsiveness (GBM only)60%*60%40%
  • NOTE. CTL responsiveness was determined from seven testable samples per trial.

  • Abbreviation: AA, anaplastic (grade III) astrocytoma.

  • * Bulk CTL assay.

  • IFN-γ production by qPCR. Eleven (7 by bulk CTL and 4 by IFN-γ qPCR) of 12 patients and 13 (1 by bulk CTL and 12 by IFN-γ qPCR) of 13 patients were tested for vaccine responsiveness from vaccine and vaccine + chemotherapy groups, respectively.