Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients with Non-small Cell Lung Cancer Refractory to Standard Therapy (Phase I study)
Phase 1
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000003189
- Lead Sponsor
- Shiga University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. Myocardial infarction within six months before entry 3. Breastfeeding and Pregnancy (woman of child bearing potential) 4. Active and uncontrolled infectious disease 5. Concurrent treatment with steroids or immunosuppressing agent 6. Other malignancy requiring treatment 7. Non-cured traumatic wound 8. Decision of unsuitableness by principal investigator or physician-in-charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of safety and tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) as well as adverse effects of vaccination therapy, and determination of the recommended dose for next phase trial.
- Secondary Outcome Measures
Name Time Method 1.Evaluation of immunological responses Peptides specific CTL responses in vitro Antigen cascade Changes in levels of regulatory T cells Expression of cancer antigens and HLA 2.Evaluation of clinical efficacy Objective response rate (by RECIST) Monitoring of tumor markers Overall survival Progression free survival