NCT01949688

Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors

Phase I/II Study Using Epitope Peptide Restricted to HLA-A*24 or HLA-A*02 in Patients With Advanced Solid Tumors That Are Refractory to Standard Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Shiga University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators examine using a combination of two types of HLA-A\*2402 (or HLA-A\*0201)-restricted epitope peptides, which were derived from VEGF-R1 and VEGF-R2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 or HLA-A\*0201 restricted epitope peptides (VEGF-R1 and VEGF-R2) emulsified with Montanide ISA 51 for advanced solid tumors. In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402 or HLA-A\*0201-positive advanced solid tumor patients who are refractory to standard therapy.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	HLA-A*2402 or A*0201 restricted peptides	Open Label, Non-Randomized, Safety/Efficacy study: 1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant. 2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.

Timeline

• Start date: 2010-06-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2013-09-24
• Last updated: 2019-03-19

Locations

1 site across 1 country: Japan