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

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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*2402
Able and willing to give valid written informed consent

Exclusion Criteria:

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

Sites / Locations

Shiga University of Medical Science Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine

Arm Description

HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Outcomes

Primary Outcome Measures

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

Evaluation of clinical efficacy: Progression free survival.

Evaluation of clinical efficacy: Tumor markers.

Evaluation of clinical efficacy: Overall survival.

Evaluation of clinical efficacy: Objective response rate.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01950156

First Posted

September 17, 2013

Last Updated

March 15, 2019

Sponsor

Shiga University

Collaborators

Tokyo University

1. Study Identification

Unique Protocol Identification Number

NCT01950156

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiga University

Collaborators

Tokyo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaccine

Arm Type

Experimental

Arm Description

HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Intervention Type

Biological

Intervention Name(s)

HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant

Intervention Description

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 Measure Information:

Title

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

Time Frame

2 months

Title

Evaluation of clinical efficacy: Progression free survival.

Time Frame

2 months

Title

Evaluation of clinical efficacy: Tumor markers.

Time Frame

2 months

Title

Evaluation of clinical efficacy: Overall survival.

Time Frame

2 months

Title

Evaluation of clinical efficacy: Objective response rate.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

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

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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*2402 Able and willing to give valid written informed consent Exclusion Criteria: 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

Facility Information:

Facility Name

Shiga University of Medical Science Hospital

City

Otsu

State/Province

Shiga

ZIP/Postal Code

520-2192

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

19459850

Citation

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.

Results Reference

background

PubMed Identifier

18770861

Citation

Harao M, Hirata S, Irie A, Senju S, Nakatsura T, Komori H, Ikuta Y, Yokomine K, Imai K, Inoue M, Harada K, Mori T, Tsunoda T, Nakatsuru S, Daigo Y, Nomori H, Nakamura Y, Baba H, Nishimura Y. HLA-A2-restricted CTL epitopes of a novel lung cancer-associated cancer testis antigen, cell division cycle associated 1, can induce tumor-reactive CTL. Int J Cancer. 2008 Dec 1;123(11):2616-25. doi: 10.1002/ijc.23823.

Results Reference

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PubMed Identifier

18452554

Citation

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.

Results Reference

background

PubMed Identifier

18297458

Citation

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.

Results Reference

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PubMed Identifier

18089789

Citation

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.

Results Reference

background

PubMed Identifier

17784873

Citation

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.

Results Reference

background

PubMed Identifier

17079454

Citation

Hayama S, Daigo Y, Kato T, Ishikawa N, Yamabuki T, Miyamoto M, Ito T, Tsuchiya E, Kondo S, Nakamura Y. Activation of CDCA1-KNTC2, members of centromere protein complex, involved in pulmonary carcinogenesis. Cancer Res. 2006 Nov 1;66(21):10339-48. doi: 10.1158/0008-5472.CAN-06-2137.

Results Reference

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

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