- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00845611
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Gastric Cancer
April 4, 2012 updated by: Hajime Ishikawa, Kinki University
Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
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 gastric cancer.
Study Overview
Detailed Description
URLC10 has 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 esophageal cancer and gastric cancer and other cancer.
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, the investigators evaluate the safety, immunological and clinical response of URLC10 peptide vaccine in the patients with gastric cancer.
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
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka
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Osakasayama, Osaka, Japan, 589-8511
- department of surgery, Kinki University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have Advanced or recurrent gastric 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.
- 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
- Decision of unsuitableness by principal investigator or physician-in-charge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
Time Frame: 28 days after beginning protocol
|
28 days after beginning protocol
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
efficacy(Feasibility as evaluated by RECIST)
Time Frame: 28 days after beginning protocol
|
28 days after beginning protocol
|
evaluate immunological responses
Time Frame: 28 days after beginning protocol
|
28 days after beginning protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hitoshi Shiozaki, MD, Department of Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (ESTIMATE)
February 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 6, 2012
Last Update Submitted That Met QC Criteria
April 4, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-27
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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