Safety Study of Multiple Peptide Vaccine to Esophageal Cancer - Full Text View

Sponsors and Collaborators:	Japanese Foundation for Cancer Research Human Genome Center, Institute of Medical Science, University of Tokyo
Information provided by:	Japanese Foundation for Cancer Research
ClinicalTrials.gov Identifier:	NCT00561275

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 I

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor

U.S. FDA Resources

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

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:

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:

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

Exclusion Criteria:

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

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:

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.

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.

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 Sep 2; [Epub ahead of print]

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

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009