Refractory cancer patients (MAGE-A4- or Survivin-expressing, non origin-limited) or the patients who refuse standard cancer therapy
Conditions
Interventions
Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-specific Th1 cells (3x10^7cells), mixed with MAGE-A4- or Survivin-hepler pepitde (0.1 mg), at every two weeks, repeated 4 times
Subcutaneo
Sponsors
Department of General Surgery, Hokkaido University Graduated School of Medicine
1) Division of Immunoregulation, Institute for Genetic Medicine, Hokkaido University 2) Bioimmulance Co. Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged twenty or more at the time of informed consent 2) Patients with histologically-confirmed malignant neoplasm 3) Therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage III or IV, recurrent cancer or patients who refuse the standard therapy 4) Patients with histologically-confirmed carcinoma. Therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage III or IV, recurrent cancer, or advanced cancer patients who refuse the standard therapy 5) Performance status (ECOG) 0 to 2 6) At least four-month life expectancy 7) Normal bone-marrow and kidney function, meeting the criteria below; Neutrophil cells>1500/microL Lymphocytes>500/microL Platelets>100000/microL Hemoglobin>8.0 g/dL Serum bilirubin<2 mg/dL Serum creatinine<2.0 mg/dL (<2.5 mg/dL in Kidney cancer) 8) PCR/ IHC-confirmed MAGA-A4 or Survivin expressing tumor cells 9) Positive for HLA-DPB1*0501, HLA-DRB1*1403, HLA-DRB1*1501, HLA-DRB1*1502, or HLA-DRB1*0101 in MAGE-A4-specific Th1 cell therapy. Positive for HLA-DRB1*0101, HLA-DR53, HLA-DQB1*0601, or HLA-DPB1*0501 in Survivin-specific Th1 cell therapy 10) Patients having written informed consent by their free will after explanation of the present study
Exclusion criteria
Exclusion criteria: 1) Patients with the previous enrollment to clinical trials of cancer immune therapy for MAGE-A4 in MAGE-A4-specific Th1 cell therapy. 2) Patients with the previous enrollment to clinical trials of cancer immune therapy for Survivin in Survivin-specific Th1 cell therapy. 3) Pregnant women or women refused anticonception during the study 4) Men refused anticonception during the study 5) Lactating women or women refused lactating during the study 6) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec Fbg<100mg/dl FDP>20mg/ml Severe bleeding case judged by an attending physician at the diagnosis 7) Active infection (HIV, HBV or HCV etc.) 8) Severe heart disease (NYHA class 3 or 4) 9) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 10) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 11) Patient with impaired mental status in the study. 12) Inappropriate for study entry judged by an attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Dose limiting toxicity (DLT) and Type, frequency, and degree of adverse events (AE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: MAGE-A4 or Survivin-antigen specific immune responses (antibody production, CD4+T and CD8+T cell responses) and antitumor action | — |
Countries
Japan
Contacts
Public ContactKitamura Hidemitsu
Division of Immunoregulation, Institute for Genetic Medicine, Hokkaido University Bureau of MAGE-A4/Survivin Th1 cell therapy clinical study
Outcome results
None listed