Safety Study of Multiple Peptide Vaccine to Esophageal Cancer

NCT00561275 | Completed Phase 1

• 1 other identifier: TB-454
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity of multiple peptide vaccinations

  one year

Secondary Outcomes (1)

• Immune responses including LY6K, VEGFR1 and VEGFR2 specific T cells

  one year

Interventions

LY6K, VEGFR1, VEGFR2 BIOLOGICAL

1 mg/body every two week with GM-CSF, 4 cycles

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• WHO performance status of 0 to 2
• Age ≥ 20 years, ≤75 years
• Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry
• Expected survival of at least 3 months
• 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
• Patients must be HLA-A2402
• Primary lesion of esophageal cancer must express LY6K
• Able and willing to give valid written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Japanese Foundation for Cancer Research: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

Takuya Takayama M.D.Ph.D

Tokyo, 135-8550, Japan

Location

Related Publications (3)

• Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.

  PMID: 17020992 BACKGROUND

• Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.

  PMID: 15930316 BACKGROUND

• 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.

  PMID: 17784873 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

LY6K protein, human; Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Takuya Takayama, M.D.Ph.D

  Cancer Institute of Japanese Foundation for Cancer Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 20, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 15, 2008

Record last verified: 2008-07

Locations

JP (1)