Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer

NCT00753844 | Completed Phase 1

• 1 other identifier: 18-29
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer.

Conditions

Esophageal Cancer

Keywords

peptide vaccine; URLC10

Outcome Measures

Primary Outcomes (1)

• Safety(Phase I:toxicities as assessed by NCI CTCAE version3)

  28 days after beginning protocol

Secondary Outcomes (2)

• efficacy(Feasibility as evaluated by RECIST)

  28 days after beginning protocol

• evaluate immunological responses

  28 days after beginning protocol

Interventions

URLC10 BIOLOGICAL

Biological: URC10 Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have Advanced or recurrent 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, ≤80 years
• The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible
• Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks.
• Expected survival of at least 3 months
• WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin ≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits
• Patients must be HLA-A2402
• Able and willing to give valid written informed consent

You may not qualify if:

• Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding
• Serious infections requiring antibiotics
• Concurrent treatment with steroids or immunosuppressing agent
• Disease to the central nervous system
• Decision of unsuitableness by principal investigator or physician-in-charge

Sponsors & Collaborators

• Kinki University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

department of surgery, Kinki University

Sayama, Osaka, 589-8511, Japan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

LY6K protein, human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of surgery

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

JP (1)