Clinical trial for safety and tolerability using an interferon-inducible dendritic cell-based vaccine
- Conditions
- Breast cancer, colorectal cancer, pancreatic cancer, gastric cancer, lung cancer
- Registration Number
- JPRN-jRCTc040200005
- Lead Sponsor
- Shimodaira Shigetaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6
1. Age at the time of informed consent: 20 to 75 years old
2. Performance status: 0/1
3. Pathological diagnosis: WT1 positive adenocarcinoma
4. Adjuvant therapy after surgical resection
5. Neither cardiovascular diseases nor respiratory disorders that would prevent blood apheresis
6. No organ function abnormalities, no blood abnormalities, no bleeding tendency
7. No infectious diseases
8. Understand the risk and benefit of the dendritic cell-vaccination
9. No other clinical trials
1. Allergy to penicillin or OK-432
2. Advanced diseases such as obstructive jaundice and involvement either in pleura or in peritoneum
3. Requiring platelet or red blood cell transfusion or albumin infusion
4. Disseminated intravascular coagulation syndrome and deep vein thrombosis
5. An infectious disease such as viral hepatitis (following the standard of the Japanese Red Cross Blood Center)
6. Past history of cerebrovascular disorders such as cerebral hemorrhage and infarction
7. Poor control of lung diseases such as chronic obstructive lung disease, bronchial asthma, and requiring oxygen dosage
8. Pneumonitis (the past)
9. Autoimmune diseases (present or the past)
10. Steroid hormone therapy continuously administered for diseases other than the prevention of temporal chemotherapeutic drug allergy
11. Mental disease (including neurosis, the panic disorder)
12. The past of epilepsy having poor control
13. Difficulty in arm vessel blood access for apheresis
14. No informed consent due to cancer
15. Inability to understand the risk and benefit of the DC vaccination
16. Pregnant or nursing women, desire to bear children
17. Under the treatment with immune checkpoint inhibitors during this clinical trial
18. Under the radiotherapy during this clinical trial
19. Physician judgment that a patient is inappropriate for treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method