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Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

This study has been completed.
Sponsor:
Collaborator:
Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:
Japanese Foundation for Cancer Research
ClinicalTrials.gov Identifier:
NCT00561275
First received: November 14, 2007
Last updated: July 10, 2008
Last verified: July 2008
History of Changes
  Purpose

This is a phase 1 study of multiple peptide vaccine therapy and GM-CSF in treating patients with esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
 Biological: LY6K, VEGFR1, VEGFR2
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Japanese Foundation for Cancer Research:

Primary Outcome Measures:
  • Toxicity of multiple peptide vaccinations [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: LY6K, VEGFR1, VEGFR2
    1 mg/body every two week with GM-CSF, 4 cycles
Detailed Description:

LY6K (lymphocyte antigen 6 complex, locus K) was identified as a new target of tumor associated antigen using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. On the other hand, anti-angiogenic therapy is now considered to be one of promising approaches to treat of cancer. In this clinical trial, we evaluate the safety and immune responses of multiple peptide cocktail including LY6K and vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) together with IFA and GM-CSF as immunoadjuvants in patients who had LY6K expressed primary esophageal cancer. Toxicity profiles will be monitored, and antigen specific T cell responses will be described.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have metastatic disease of esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
  2. WHO performance status of 0 to 2
  3. Age ≥ 20 years, ≤75 years
  4. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
  5. Expected survival of at least 3 months
  6. WBC≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
  7. Patients must be HLA-A2402
  8. Primary lesion of esophageal cancer must express LY6K
  9. Able and willing to give valid written informed consent

Exclusion Criteria:

  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Serious infections requiring antibiotics
  4. Patient with peptic ulcer disease
  5. Previous history of intestinal perforation
  6. bleeding disorders (INR ≥ 1.5)
  7. Necessity of drug-mediated inhibition with platelet function
  8. Taking antithrombogenic agents within 10 days
  9. Serious hypertension
  10. Previous history of arterial thrombosis or venous thrombosis
  11. Other malignancy within 5 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
  12. Clinically significant heart disease or previous history of myocardial infarction within the past 12 months
  13. Concomitant treatment with steroids or immunosuppressing agent
  14. Disease to the central nervous system
  15. Decision of unsuitableness by principal investigator or physician-in-charge
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561275

Locations
Japan
Takuya Takayama M.D.Ph.D
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Japanese Foundation for Cancer Research
Human Genome Center, Institute of Medical Science, University of Tokyo
Investigators
Principal Investigator: Takuya Takayama, M.D.Ph.D Cancer Institute of Japanese Foundation for Cancer Research
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00561275     History of Changes
Other Study ID Numbers: TB-454
Study First Received: November 14, 2007
Last Updated: July 10, 2008
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013