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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

November 14, 2007
July 10, 2008
October 2007
May 2008   (final data collection date for primary outcome measure)
Toxicity of multiple peptide vaccinations [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: one year ]
Complete list of historical versions of study NCT00561275 on ClinicalTrials.gov Archive Site
Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells [ Time Frame: one year ] [ Designated as safety issue: Yes ]
• Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells [ Time Frame: one year ]
Not Provided
Not Provided
 
Safety Study of Multiple Peptide Vaccine to Esophageal Cancer
Phase 1 Study of Multiple Peptide Vaccine Therapy and GM-CSF in Treating Patients With Esophageal Cancer

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
Biological: LY6K, VEGFR1, VEGFR2
1 mg/body every two week with GM-CSF, 4 cycles
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00561275
TB-454
No
Not Provided
Japanese Foundation for Cancer Research
Human Genome Center, Institute of Medical Science, University of Tokyo
Principal Investigator: Takuya Takayama, M.D.Ph.D Cancer Institute of Japanese Foundation for Cancer Research
Japanese Foundation for Cancer Research
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP