Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer - Full Text View

Purpose

The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: S-488410	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Shiga University:

Primary Outcome Measures:

Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients. [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CTL response between HLA-A24:02 and non-HLA-A24:02 [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]
PFS and ORR between HLA-A24:02 and non-HLA-A24:02 [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]
PFS and OS between CTL response positive and negative [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]
Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]
Identification of biomarkers for efficacy and safety that are mentioned above [ Time Frame: Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year. ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	May 2012
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: S-488410	Drug: S-488410 In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each). Other Name: S-488410 (S-488401, S-488402, S-488403).

Detailed Description:

The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.

The investigators previously identified three novel HLA-A*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced NSCLC that cannot undergo curative surgery.
Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
Histologically diagnosed NSCLC.
Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
Life expectancy > 3 months.
Age between 20 to 79
Male or Female.
In patients or out patients.
Able and willing to give valid written informed consent.

Exclusion Criteria:

Other malignancy requiring treatment
radiation, immunotherapy, hyperthermia, or surgery.
Active and uncontrolled infectious disease
Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
Autoimmune disease.
HIV-Ab or antigen positive
Prior anti-cancer therapy within 4 weeks
Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
Patients knows HLA-A type.
Breastfeeding and Pregnancy (woman of child bearing potential)
Refusal of pregnancy conception.
Treated with S-488401, S-488402, or S-488403.
Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592617

Locations

Japan
Department of Medical Oncology, Shiga University of Medical Science Hospital	Recruiting
Otsu, Shiga, Japan, 520-2192
Contact: Yataro Daigo, MD, PhD 81-77-548-2111
Principal Investigator: Yataro Daigo, MD, PhD

Sponsors and Collaborators

Shiga University

Showa University

Fukushima Medical University

Tohoku University

Shionogi

Investigators

Principal Investigator:

Yataro Daigo, MD, PhD

Department of Medical Oncology, Shiga University of Medical Science

More Information

Additional Information:

Click here for more information about this study. This link exits the ClinicalTrials.gov site

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. Epub 2009 May 14.

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.

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. Epub 2008 Apr 30.

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. Epub 2008 Feb 24. Review.

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.

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 Sep 2; [Epub ahead of print]

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.

Responsible Party:	Yataro Daigo, Professor, Director of Cancer Center, Shiga University
ClinicalTrials.gov Identifier:	NCT01592617 History of Changes
Other Study ID Numbers:	S488410LP, UMIN000007873
Study First Received:	May 2, 2012
Last Updated:	May 4, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Shiga University:

cancer vaccine
HLA-A*24:02
lung cancer
CTL

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic

Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013