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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949701
• Other study ID #: SUMS-23-56
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2011
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Japan	Shiga University of Medical Science Hospital	Ohtsu	Shiga

Sponsors (2)

Lead Sponsor	Collaborator
Shiga University	Tokyo University

Country where clinical trial is conducted

Japan, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of safety: the number of adverse events of vaccination therapy.		2 months
Primary	Evaluation of clinical efficacy: Progression free survival.		2 months
Primary	Evaluation of clinical efficacy: Tumor markers.		2 months
Primary	Evaluation of clinical efficacy: Overall survival.		2 months
Primary	Evaluation of clinical efficacy: Objective response rate.		2 months
Secondary	Various immunological responses including peptides specific CTL, antigen cascade, regulatory T cells, cancer antigens and HLA levels.		2 months