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Non-small Cell Lung CancerPhase 1/2NCT01949701

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

A Phase 1/2 study testing HLA-A*0201restricted URLC10 peptides with adjuvant in people with Non-small Cell Lung Cancer, run by Shiga University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
HLA-A*0201restricted URLC10 peptides with adjuvant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteJapan
Study dates
Aug 2011to Mar 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • ECOG performance status 0-2
  • Age between 20 to 85
  • Clinical efficacy can be evaluated by some methods
  • No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
  • Life expectancy > 3 months
Show all 9Show fewer
  • 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
  • HLA-A*0201
  • Able and willing to give valid written informed consent

Who cannot join

  • Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
  • Myocardial infarction within six months before entry
  • Breastfeeding and Pregnancy (woman of child bearing potential)
  • Active and uncontrolled infectious disease
  • Concurrent treatment with steroids or immunosuppressing agent
  • Other malignancy requiring treatment
  • Non-cured traumatic wound
  • Decision of unsuitableness by principal investigator or physician-in-charge

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Shiga University of Medical Science Hospital

    Ohtsu, Shiga, 520-2192

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
HLA-A*0201restricted URLC10 peptides with adjuvant
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLA-A*0201restricted URLC10 peptides with adjuvantBiological

    Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*0201restricted URLC10 peptides with adjuvant.

Study groups in NCT01949701
Study groupRoleWhat they receive
VaccineExperimentalHLA-A*0201restricted URLC10 peptides
Receives: Biological: HLA-A*0201restricted URLC10 peptides with adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of safety: the number of adverse events of vaccination therapy.

    Measured: 2 months

  2. Evaluation of clinical efficacy: Progression free survival.

    Measured: 2 months

  3. Evaluation of clinical efficacy: Tumor markers.

    Measured: 2 months

  4. Evaluation of clinical efficacy: Overall survival.

    Measured: 2 months

  5. Evaluation of clinical efficacy: Objective response rate.

    Measured: 2 months

Secondary outcomes (1)

  1. Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949701
Sponsor's protocol ID
SUMS-23-56
Status last verified
Mar 2019
First submitted
20 Sep 2013
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14.

    PubMed 19459850

  • Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30.

    PubMed 18452554

  • Daigo Y, Nakamura Y. From cancer genomics to thoracic oncology: discovery of new biomarkers and therapeutic targets for lung and esophageal carcinoma. Gen Thorac Cardiovasc Surg. 2008 Feb;56(2):43-53. doi: 10.1007/s11748-007-0211-x. Epub 2008 Feb 24.

    PubMed 18297458

  • Ishikawa N, Takano A, Yasui W, Inai K, Nishimura H, Ito H, Miyagi Y, Nakayama H, Fujita M, Hosokawa M, Tsuchiya E, Kohno N, Nakamura Y, Daigo Y. Cancer-testis antigen lymphocyte antigen 6 complex locus K is a serologic biomarker and a therapeutic target for lung and esophageal carcinomas. Cancer Res. 2007 Dec 15;67(24):11601-11. doi: 10.1158/0008-5472.CAN-07-3243.

    PubMed 18089789

  • Suda T, Tsunoda T, Daigo Y, Nakamura Y, Tahara H. Identification of human leukocyte antigen-A24-restricted epitope peptides derived from gene products upregulated in lung and esophageal cancers as novel targets for immunotherapy. Cancer Sci. 2007 Nov;98(11):1803-8. doi: 10.1111/j.1349-7006.2007.00603.x.

    PubMed 17784873

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HLA-A*0201restricted URLC10 peptides with adjuvant in people with Non-small Cell Lung Cancer, run by Shiga University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of safety: the number of adverse events of vaccination therapy. (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949701, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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