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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Showa University
Fukushima Medical University
Tohoku University
Shionogi
Information provided by (Responsible Party):
Yataro Daigo, Shiga University
ClinicalTrials.gov Identifier:
NCT01592617
First received: May 2, 2012
Last updated: September 17, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: May 2, 2012
Last Updated: September 17, 2013
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 July 20, 2014