Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 Disease Controlled Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950156
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Tokyo University
Information provided by (Responsible Party):
Yataro Daigo, Shiga University

Brief Summary:
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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine
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.




Primary Outcome Measures :
  1. Evaluation of safety: the number of adverse events of vaccination therapy. [ Time Frame: 2 months ]
  2. Evaluation of clinical efficacy: Progression free survival. [ Time Frame: 2 months ]
  3. Evaluation of clinical efficacy: Tumor markers. [ Time Frame: 2 months ]
  4. Evaluation of clinical efficacy: Overall survival. [ Time Frame: 2 months ]
  5. Evaluation of clinical efficacy: Objective response rate. [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Various immunological responses comprising peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Japan
Shiga University of Medical Science Hospital
Otsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Tokyo University

Publications:

Layout table for additonal information
Responsible Party: Yataro Daigo, Professor, Shiga University
ClinicalTrials.gov Identifier: NCT01950156    
Other Study ID Numbers: SUMS-23-57
23-57 ( Other Identifier: Shiga University )
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Chenodeoxycholic Acid
Cathartics
Gastrointestinal Agents