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

NCT00845611 | Completed Phase 1 DMC

• 1 other identifier: 20-27
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

peptide vaccine; URLC10

Outcome Measures

Primary Outcomes (1)

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

  28 days after beginning protocol

Secondary Outcomes (2)

• efficacy(Feasibility as evaluated by RECIST)

  28 days after beginning protocol

• evaluate immunological responses

  28 days after beginning protocol

Interventions

peptide vaccine BIOLOGICAL

peptides emulsified with Montanide ISA51

Also known as: Peptides Drived From URLC10 emulsified with Montanide ISA51

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinki University: lead
• Human Genome Center, Institute of Medical Science, University of Tokyo: collaborator

Study Sites (1)

department of surgery, Kinki University

Sayama, Osaka, 589-8511, Japan

Location

Related Publications (1)

• 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.

  PMID: 23613128 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Protein Subunit Vaccines; montanide ISA 51

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hitoshi Shiozaki, MD

  Department of Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of surgery

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

JP (1)