Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients With Disease Controlled Advanced Non-small Cell Lung Cancer
| Registry | NCT01950156 |
|---|---|
| Status | Completed |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 6 (Estimated) |
| Sponsor | Shiga University (Other); collaborators: Tokyo University |
| Conditions | Non-small Cell Lung Cancer |
| Interventions | HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant (Biological) |
| Dates | start 2011-09-01, primary completion 2019-03-01, completion 2019-03-01, first posted 2013-09-25, last updated 2019-03-19 |
| Locations | 1 site in Japan |
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All trials for Non-small Cell Lung Cancer All trials of HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for disease controlled advanced non-small cell lung cancers.
The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I/II trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vaccine | Experimental | Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant | HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant |
Sex: All, ages: 20 Years to 85 Years
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*2402 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
| Facility | City | Country | Status |
|---|---|---|---|
| Shiga University of Medical Science Hospital | Ōtsu, Shiga | Japan |