Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Tokyo University Human Genome Center, Institute of Medical Science, University of Tokyo |
---|---|
Information provided by: | Tokyo University |
ClinicalTrials.gov Identifier: | NCT00681421 |
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.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Biological: URLC10, VEGFR1 and VEGFR2 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Esophageal Cancer |
Estimated Enrollment: | 14 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Biological: URLC10, VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
|
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.
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hideki Ohno, MD/PhD | +81-3-5449-5772 | hidekioono-gi@umin.ac.jp |
Japan, Tokyo | |
The Institutute of Medical Science, University of Tokyo | Recruiting |
4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan, 108-8639 | |
Contact: Hideki Ohno, MD/PhD 03-5449-5772 hidekioono-gi@umin.ac.jp |
Study Chair: | Naohide Yamashita, MD/PhD | The Institute of Medical Science, The University of Tokyo |
Responsible Party: | The Institute of Medical Science, The University of Tokyo ( Naohida Yamashita, MD/PhD ) |
Study ID Numbers: | IMS-OKA0201 |
Study First Received: | May 19, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00681421 |
Health Authority: | Japan: Institutional Review Board |
Peptide Vaccine URLC10 VEGFR1 VEGFR2 |
Digestive System Neoplasms Digestive System Diseases Esophageal disorder Gastrointestinal Diseases Head and Neck Neoplasms |
Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Neoplasms Neoplasms by Site |