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

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ClinicalTrials.gov Identifier: NCT01592617
Recruitment Status : Unknown
Verified August 2015 by Yataro Daigo, Shiga University.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2012
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: S-488410 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Study Start Date : May 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592617


Locations
Japan
Department of Medical Oncology, Shiga University of Medical Science Hospital
Otsu, Shiga, Japan, 520-2192
Sponsors and Collaborators
Shiga University
Showa University
Fukushima Medical University
Tohoku University
Shionogi
Tokyo University
University of Chicago
Investigators
Principal Investigator: Yataro Daigo, MD, PhD Department of Medical Oncology, Shiga University of Medical Science
More Information

Additional Information:
Publications:

Responsible Party: Yataro Daigo, Professor of Medical Oncology, Director of Cancer Center, Shiga University
ClinicalTrials.gov Identifier: NCT01592617     History of Changes
Other Study ID Numbers: S488410LP
UMIN000007873 ( Registry Identifier: UMIN: University Hospital Medical Information Network )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Yataro Daigo, Shiga University:
cancer vaccine
HLA-A*24:02
lung cancer
CTL

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms