Esophageal Cancer
Conditions
Keywords
Peptide Vaccine, URLC10, TTK, KOC1
Brief summary
The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
Detailed description
URLC10, KOC1 and TTK have 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, KOC1 and TTK are upregulated in human esophageal tumors. We identified that peptides derived from these proteins 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 peptide (1mg), KOC1 peptide (1mg), and TTK 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.
Interventions
BIOLOGICALURC10, TTK, KOC1
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Sponsors
Human Genome Center, Institute of Medical Science, University of Tokyo
Tokyo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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\*2402 * 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST) | Two months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate immunological responses | Two months |
Countries
Japan
Outcome results
None listed