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

Esophageal Cancer Clinical Trial

Official title:

Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753844
• Other study ID #: 18-29
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2008
• Last updated: April 4, 2012
• Start date: November 2006
• Est. completion date: July 2009

Study information

• Verified date: April 2012
• Source: Kinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

URLC10 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 are upregulated in human esophageal tumors. The investigators identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of URLC10 peptide. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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

2. WHO performance status of 0 to 2

3. Age = 20 years, =80 years

4. The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible

5. Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks.

6. Expected survival of at least 3 months

7. 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

8. Patients must be HLA-A2402

9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding

2. Serious infections requiring antibiotics

3. Concurrent treatment with steroids or immunosuppressing agent

4. Disease to the central nervous system

5. Decision of unsuitableness by principal investigator or physician-in-charge

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Biological:
• URLC10
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.

Locations

Country	Name	City	State
Japan	department of surgery, Kinki University	Osakasayama	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Kinki University	Human Genome Center, Institute of Medical Science, University of Tokyo

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety(Phase I:toxicities as assessed by NCI CTCAE version3)		28 days after beginning protocol	Yes
Secondary	efficacy(Feasibility as evaluated by RECIST)		28 days after beginning protocol	No
Secondary	evaluate immunological responses		28 days after beginning protocol	No