Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01950156|
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 2019|
HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.
- Evaluation of safety: the number of adverse events of vaccination therapy. [ Time Frame: 2 months ]
- Evaluation of clinical efficacy: Progression free survival. [ Time Frame: 2 months ]
- Evaluation of clinical efficacy: Tumor markers. [ Time Frame: 2 months ]
- Evaluation of clinical efficacy: Overall survival. [ Time Frame: 2 months ]
- Evaluation of clinical efficacy: Objective response rate. [ Time Frame: 2 months ]
- Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950156
|Shiga University of Medical Science Hospital|
|Otsu, Shiga, Japan, 520-2192|