Description:
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.
Title
- Brief Title: Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
SUMS-23-57
- SECONDARY ID:
23-57
- NCT ID:
NCT01950156
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant | | Vaccine |
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Vaccine | Experimental | HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant | - HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
|
Eligibility Criteria
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
Maximum Eligible Age: | 85 Years |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluation of safety: the number of adverse events of vaccination therapy. |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Shiga University |
Last Updated
March 19, 2019