Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
S-488410
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring cancer vaccine, HLA-A*24:02, lung cancer, CTL
Eligibility 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.
Sites / Locations
- Department of Medical Oncology, Shiga University of Medical Science Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-488410
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
Secondary Outcome Measures
CTL response between HLA-A24:02 and non-HLA-A24:02
PFS and ORR between HLA-A24:02 and non-HLA-A24:02
PFS and OS between CTL response positive and negative
Safety and tolerability: Number of Adverse Events with information of disease, grade and incidence
Identification of biomarkers for efficacy and safety that are mentioned above
Full Information
NCT ID
NCT01592617
First Posted
May 2, 2012
Last Updated
August 11, 2015
Sponsor
Shiga University
Collaborators
Showa University, Fukushima Medical University, Tohoku University, Shionogi, Tokyo University, University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01592617
Brief Title
Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
Official Title
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiga University
Collaborators
Showa University, Fukushima Medical University, Tohoku University, Shionogi, Tokyo University, University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
cancer vaccine, HLA-A*24:02, lung cancer, CTL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-488410
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-488410
Other Intervention Name(s)
S-488410 (S-488401, S-488402, S-488403).
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
Department of Medical Oncology, 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
background
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
background
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
background
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
background
Links:
URL
http://www.shiga-med.ac.jp/~hqchiken/
Description
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Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer
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