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Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive 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*0201 or HLA-A*0206-restricted URLC10 peptides

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring URLC10, lung cancer, vaccine, HLA-A*0201, HLA-A*0206

Eligibility Criteria

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

Inclusion Criteria:

NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
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 4 weeks
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*0201 or HLA-A*0206
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 2

Arm 3

Arm Type

Experimental

Arm Label

URLC10-1mg

URLC10-2mg

URLC10-3mg

Arm Description

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A*0201 or HLA-A*0206-restricted URLC10 peptide (3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Outcomes

Primary Outcome Measures

Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.

Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.

Secondary Outcome Measures

Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.

Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.

Full Information

NCT ID

NCT01069640

First Posted

February 16, 2010

Last Updated

March 15, 2019

Sponsor

Shiga University

Collaborators

Human Genome Center, Institute of Medical Science, University of Tokyo

1. Study Identification

Unique Protocol Identification Number

NCT01069640

Brief Title

Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer

Official Title

Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*02 (URLC10) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

February 2010 (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

Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.

Detailed Description

The investigators previously identified three novel HLA-A*0201 or HLA-A*0206-restricted epitope peptides, which were derived from a cancer-testis antigen, URLC10, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HHLA-A*0201 or HLA-A*0206-positive advanced non-small cell lung cancer patients who failed to standard therapy.

6. Conditions and Keywords

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

Non-small Cell Lung Cancer

Keywords

URLC10, lung cancer, vaccine, HLA-A*0201, HLA-A*0206

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

URLC10-1mg

Arm Type

Experimental

Arm Description

Arm Title

URLC10-2mg

Arm Type

Experimental

Arm Description

Arm Title

URLC10-3mg

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides

Other Intervention Name(s)

URLC10

Intervention Description

Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.

Primary Outcome Measure Information:

Title

Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.

Time Frame

2 months

Title

Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.

Time Frame

2 months (every time point(s) at which each course is completed)

Title

Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.

Time Frame

2 months (every time point(s) at which each course is completed)

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 that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy 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 4 weeks 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*0201 or HLA-A*0206 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yataro Daigo, MD, PhD

Organizational Affiliation

Department of Medical Oncology, Shiga University of Medical Science

Official's Role

Principal Investigator

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

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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 Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer

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