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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
URLC10-1mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides (Biological)
URLC10-2mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides (Biological)
URLC10-3mg
Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides (Biological)
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))
Investigators
Yataro Daigo
Professor, Director of Cancer Center
Shiga University