Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*02 (URLC10) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Shiga University
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.
Detailed Description
The investigators previously identified three novel HLA-A\*0201 or HLA-A\*0206-restricted epitope peptides, which were derived from a cancer-testis antigen, URLC10, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HHLA-A\*0201 or HLA-A\*0206-positive advanced non-small cell lung cancer patients who failed to standard therapy.
Investigators
Yataro Daigo
Professor, Director of Cancer Center
Shiga University
Eligibility Criteria
Inclusion Criteria
- •NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
- •ECOG performance status 0-2
- •Age between 20 to 85
- •Clinical efficacy can be evaluated by some methods
- •No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
- •Life expectancy \> 3 months
- •Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
- •HLA-A\*0201 or HLA-A\*0206
- •Able and willing to give valid written informed consent
Exclusion Criteria
- •Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
- •Myocardial infarction within six months before entry
- •Breastfeeding and Pregnancy (woman of child bearing potential)
- •Active and uncontrolled infectious disease
- •Concurrent treatment with steroids or immunosuppressing agent
- •Other malignancy requiring treatment
- •Non-cured traumatic wound
- •Decision of unsuitableness by principal investigator or physician-in-charge
Outcomes
Primary Outcomes
Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.
Time Frame: 2 months
Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.
Time Frame: 2 months
Secondary Outcomes
- Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.(2 months (every time point(s) at which each course is completed))
- Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.(2 months (every time point(s) at which each course is completed))