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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01592617
• Other study ID #: S488410LP
• Secondary ID: UMIN000007873
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 2, 2012
• Last updated: August 11, 2015
• Start date: May 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2015
• Source: Shiga University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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).

Locations

Country	Name	City	State
Japan	Department of Medical Oncology, Shiga University of Medical Science Hospital	Otsu	Shiga

Sponsors (7)

Lead Sponsor	Collaborator
Shiga University	Fukushima Medical University, Shionogi, Showa University, Tohoku University, Tokyo University, University of Chicago

Country where clinical trial is conducted

Japan, 

References & Publications (7)

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

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. — View 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. — 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 difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No
Secondary	CTL response between HLA-A24:02 and non-HLA-A24:02		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No
Secondary	PFS and ORR between HLA-A24:02 and non-HLA-A24:02		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No
Secondary	PFS and OS between CTL response positive and negative		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No
Secondary	Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No
Secondary	Identification of biomarkers for efficacy and safety that are mentioned above		Participants will be followed for the duration of vaccination therapy, an expected average of more than 1 year.	No

External Links

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