Phase II clinical trial of personalized peptide vaccination for malignant brain tumor patients

INTERVENTION: (1st treatment: total 6 times, every weeks) Day 1: Select peptide candidates (up to 4), to which peptide‐specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide). Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 45: Final evaluation. The 1st treatment (total 6 times, every weeks) is finished CONDITION: malignant brain tumor PRIMARY OUTCOME: Evaluation of immunological responses (anti‐peptide IgG) before and after peptide vaccination. SECONDARY OUTCOME: 1. Evaluation of long‐term prognosis (progression free survival and total survival).; 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI‐CTC. INCLUSION CRITERIA: The subjects must be satisfactory the following conditions. 1 patients must be diagnosed as malignant brain tumor. The patients must be suffering from malignant brain tumor after the standard therapy. 2 patients must be positive for HLA‐A2,A24,A26 or A3 supertype. 3 patients must have immunoglobulin g reactive to at least two of candidate peptides. 4 patients must be at a score level 0‐1 of performance status. 5 patients must be expected to survive more than 3 months. 6 Patients must satisfy the followings WBC is more than 2500 per mm3 Lymphocyte is more than 900 per mm3 Hb is more than 8 g per dl Platelet is more than 80000 per mm3 Serum creatinine is less than 2 times upper limit of normal Total bilirubin is less than 2 times upper limmit of normal 7 patients must be more 16 year old. 8 written informed consent must be obtained from patients.