Non-small Cell Lung Cancer
Conditions
Keywords
URLC10, lung cancer, vaccine, HLA-A*0201, HLA-A*0206
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.
Interventions
BIOLOGICALHLA-A*0201 or HLA-A*0206-restricted URLC10 peptides
Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Shiga University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy 2. ECOG performance status 0-2 3. Age between 20 to 85 4. Clinical efficacy can be evaluated by some methods 5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks 6. Life expectancy \> 3 months 7. 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 8. HLA-A\*0201 or HLA-A\*0206 9. Able and willing to give valid written informed consent
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy. | 2 months |
| Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Countries
Japan
Outcome results
None listed