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

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
URLC10
Sponsored by
Kinki University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring peptide vaccine, URLC10

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • department of surgery, Kinki University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

efficacy(Feasibility as evaluated by RECIST)
evaluate immunological responses

Full Information

First Posted
September 16, 2008
Last Updated
April 4, 2012
Sponsor
Kinki University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo
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1. Study Identification

Unique Protocol Identification Number
NCT00753844
Brief Title
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer
Official Title
Tumor Vaccine Therapy Against Advanced Esophageal Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kinki University
Collaborators
Human Genome Center, Institute of Medical Science, University of Tokyo

4. Oversight

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
peptide vaccine, URLC10

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
URLC10
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
Time Frame
28 days after beginning protocol
Secondary Outcome Measure Information:
Title
efficacy(Feasibility as evaluated by RECIST)
Time Frame
28 days after beginning protocol
Title
evaluate immunological responses
Time Frame
28 days after beginning protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
department of surgery, Kinki University
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan

12. IPD Sharing Statement

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

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