Non-small Cell Lung Cancer
Conditions
Brief summary
The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for vaccination against lung cancer. In this clinical study, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.
Detailed description
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*0201 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers. The investigators previously identified a novel HLA-A\*0201-restricted epitope peptide, which was derived from a cancer-testis antigen, URLC10 as a target for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using the peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*0201-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies, but who do not have any options for additional standard ones to prevent .future relapse of the disease.
Interventions
BIOLOGICALHLA-A*0201restricted URLC10 peptides with adjuvant
Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A\*0201restricted URLC10 peptides with adjuvant.
Sponsors
Tokyo University
Shiga University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease. 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 appropriate periods 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 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 clinical efficacy: Tumor markers. | 2 months |
| Evaluation of clinical efficacy: Overall survival. | 2 months |
| Evaluation of clinical efficacy: Objective response rate. | 2 months |
| Evaluation of safety: the number of adverse events of vaccination therapy. | 2 months |
| Evaluation of clinical efficacy: Progression free survival. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels. | 2 months |
Countries
Japan
Outcome results
None listed