Clinical trial NCT00845611: Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Gastric Cancer
Official title: Tumor Vaccine Therapy Against Advanced Gastric Cancer Using HLA-A*2402 Restricted Epitope Peptides Drived From URLC10
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Keywords: peptide vaccine
URLC10
Lead sponsor: Kinki University
Sponsor class: OTHER
Collaborators: name: Human Genome Center, Institute of Medical Science, University of Tokyo
First posted: 2009-02-18
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Safety(Phase I:toxicities as assessed by NCI CTCAE version3)
timeFrame: 28 days after beginning protocol
Secondary outcomes:
measure: efficacy(Feasibility as evaluated by RECIST)
timeFrame: 28 days after beginning protocol
measure: evaluate immunological responses
timeFrame: 28 days after beginning protocol
Other outcomes:
Locations:
city: Osakasayama
country: Japan
facility: department of surgery, Kinki University
state: Osaka
Study officials:
affiliation: Department of Surgery
name: Hitoshi Shiozaki, MD
role: STUDY_CHAIR
References:
citation: 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.