Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer

Phase 1

Completed

• Conditions: Esophageal Cancer
• Interventions: Biological: URLC10, VEGFR1 and VEGFR2

• Registration Number: NCT00681421
• Lead Sponsor: Tokyo University

Brief Summary

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

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 is upregulated in human esophageal tumors. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccines. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Advanced or recurrent esophageal cancer
• Resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
• ECOG performance status 0-2
• Life expectancy > 3 months
• HLA-A*0201
• Laboratory values as follows 2000/mm3<WBC<15000/mm3 Platelet count>100000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 150IU/L Alanine transaminase < 150IU/L Creatinine < 3.0mg/dl
• Able and willing to give valid written informed consent

Exclusion Criteria

• Pregnancy (woman of childbearing potential:Refusal or inability to use effective means of contraception)
• Breastfeeding
• Active or uncontrolled infection
• Unhealed external wound
• Concurrent treatment with steroids or immunosuppressing agent
• Prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks
• Uncontrolled brain and/or intraspinal metastasis
• Decision of unsuitableness by principal investigator or physician-in-charge

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	URLC10, VEGFR1 and VEGFR2	-

Primary Outcome Measures

Name	Time	Method
Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)	two months

Secondary Outcome Measures

Name	Time	Method
To evaluate immunological responses	two months

Trial Locations

Locations (1)

The Institutute of Medical Science, University of Tokyo; 🇯🇵 4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan