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

NCT ID: NCT01069640

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2019-03-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URLC10-1mg

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

URLC10-2mg

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

URLC10-3mg

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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.

Interventions

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

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

URLC10

Eligibility Criteria

Inclusion Criteria

1. NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy

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 4 weeks

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 or HLA-A*0206

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Shiga University

OTHER

Sponsor Role: lead

Responsible Party

Yataro Daigo

Professor, Director of Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yataro Daigo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Shiga University of Medical Science

Locations

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 19459850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18770861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18452554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18297458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18089789 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17784873 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17079454 (View on PubMed)

Other Identifiers

UMIN000003190

Identifier Type: OTHER

Identifier Source: secondary_id

SUMS-21-73

Identifier Type: -

Identifier Source: org_study_id