A phase I clinical study of immune cell therapy with MAGE-A4- or Survivin-specific Th1 cells for patients with refractory virulent tumors
- Conditions
- Refractory cancer patients (MAGE-A4- or Survivin-expressing, non origin-limited) or the patients who refuse standard cancer therapy
- Registration Number
- JPRN-UMIN000004828
- Lead Sponsor
- Department of General Surgery, Hokkaido University Graduated School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Dose limiting toxicity (DLT) and Type, frequency, and degree of adverse events (AE)
- Secondary Outcome Measures
Name Time Method Efficacy: MAGE-A4 or Survivin-antigen specific immune responses (antibody production, CD4+T and CD8+T cell responses) and antitumor action