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

NCT ID: NCT00845611

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-09-30

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

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

peptide vaccine

peptides emulsified with Montanide ISA51

Intervention Type: BIOLOGICAL

Other Intervention Names

Peptides Drived From URLC10 emulsified with Montanide ISA51

Eligibility Criteria

Inclusion Criteria

1. 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

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.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Human Genome Center, Institute of Medical Science, University of Tokyo

OTHER

Sponsor Role: collaborator

Kinki University

OTHER

Sponsor Role: lead

Responsible Party

Hajime Ishikawa

department of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hitoshi Shiozaki, MD

Role: STUDY_CHAIR

Department of Surgery

Locations

department of surgery, Kinki University

Sayama, Osaka, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 23613128 (View on PubMed)

Other Identifiers

20-27

Identifier Type: -

Identifier Source: org_study_id