Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide... | NCT00845611

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

NCT00845611

Sponsor

Kinki University

Status

Completed

Last Update Posted

Apr 6, 2012Estimated

Enrollment

9Actual

Phase

Phase 1

Conditions

Gastric Cancer

Interventions

peptide vaccine

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2012

Last Update Posted Date

Apr 6, 2012Estimated

Name	Class
Human Genome Center, Institute of Medical Science, University of Tokyo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 gastric cancer.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
peptide vaccine	Biological	peptides emulsified with Montanide ISA51		Peptides Drived From URLC10 emulsified with Montanide ISA51

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety(Phase I:toxicities as assessed by NCI CTCAE version3)		28 days after beginning protocol

Secondary Outcomes

Measure	Description	Time Frame
efficacy(Feasibility as evaluated by RECIST)		28 days after beginning protocol
evaluate immunological responses		28 days after beginning protocol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hitoshi Shiozaki, MD	Department of Surgery	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
department of surgery, Kinki University		Sayama	Osaka	589-8511	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23613128	Derived	Ishikawa H, Imano M, Shiraishi O, Yasuda A, Peng YF, Shinkai M, Yasuda T, Imamoto H, Shiozaki H. Phase I clinical trial of vaccination with LY6K-derived peptide in patients with advanced gastric cancer. Gastric Cancer. 2014 Jan;17(1):173-80. doi: 10.1007/s10120-013-0258-6. Epub 2013 Apr 24.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000096202	Protein Subunit Vaccines
C477385	montanide ISA 51

ID	Term
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit
D014612	Vaccines
D001688	Biological Products