MAGE-A4- or Survivin-expressing refractory cancer patients (non origin-limited) or patients who refuse standard cancer therapy
Conditions
Interventions
Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-hepler pepitde (1 mg) vaccine, mixed with Montanide and OK432 (Picibanil
0.2 KE), at every two weeks, repeated 4 times
Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-hepler pepitde (10 mg) vaccine, mixed with Montanide and OK432 (Picibanil
0.2 KE), at every two weeks, repeated 4 times
Sponsors
Department of General Surgery, Hokkaido University Graduated School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically-confirmed malignant tumor, therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage 3 or 4, recurrent cancer, or advanced cancer patients who refuse the standard therapy 2) Performance status (ECOG) 0 to 2 3) Aged twenty or more 4) At least three-month life expectancy 5) Normal bone-marrow and kidney function, meeting the criteria below; Neutrophil cells>1500/mL Lymphocytes>500/mL Platelets>100000/mL Hemoglobin>8.0 g/dL Serum bilirubin<2 mg/dL Serum creatinine<2.0 mg/dL (<2.5 mg/dL in Kidney cancer) 6) PCR/ IHC-confirmed MAGA-A4 or Survivin expressing tumor cells 7) Positive for HLA-DPB1*0501, HLA-DRB1*1403, HLA-DRB1*1501, or HLA-DRB1*1502 in MAGE-A4 helper peptide vaccine. Positive for HLA-DRB1*0101, HLA-DR53, HLA-DQB1*0601 in Survivin helper peptide vaccine. 8) Having written informed consent
Exclusion criteria
Exclusion criteria: 1) Pregnant women or refuse anticonception during the study (both sexes) 2) Lactating women 3) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec Fbg<100mg/dl FDP>20mg/ml 4) Active infection (HIV, HBV or HCV etc.) 5) Severe heart disease (NYHA class 3 or 4) 6) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 7) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 8) Patient with impaired mental status in the study. 9) Inappropriate for study entry judged by an attending physician
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: MAGE-A4 or Survivin-specific immune responses (Antibody production, Induction of antigen specific CD4+T and CD8+T cells), evaluated by ELISA or ELISPOT, and tumor responses, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). | — |
Primary
| Measure | Time frame |
|---|---|
| Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. | — |
Countries
Japan
Contacts
Public ContactTogashi Yuji
Bioimmulance Co. Ltd. Bureau of MAGE-A4/Survivin peptide vaccine clinical study
Outcome results
None listed