Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*02 Disease Controlled Advanced Non-small Cell Lung Cancer

March 15, 2019 updated by: Yataro Daigo, Shiga University

Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 (URLC10) in Patients With Disease Controlled Advanced Non-small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Shiga
      • Ohtsu, Shiga, Japan, 520-2192
        • Shiga University Of Medical Science Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine
HLA-A*0201restricted URLC10 peptides
Biological: HLA-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety: the number of adverse events of vaccination therapy.
Time Frame: 2 months
2 months
Evaluation of clinical efficacy: Overall survival.
Time Frame: 2 months
2 months
Evaluation of clinical efficacy: Progression free survival.
Time Frame: 2 months
2 months
Evaluation of clinical efficacy: Tumor markers.
Time Frame: 2 months
2 months
Evaluation of clinical efficacy: Objective response rate.
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiga University

Collaborators

Tokyo University

Investigators

  • Principal Investigator: Yataro Daigo, MD, PhD, Shiga University Of Medical Science Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

September 20, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMS-23-56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

Clinical Trials on HLA-A*0201restricted URLC10 peptides with adjuvant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe