NCT01259505

Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tokyo Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of HLA-A\*2402 restricted epitope peptides CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 emulsified with Montanide ISA 51.

Detailed description

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\*2402 restricted epitope peptides derived from these molecules and identified that these peptides 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 these peptides. Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) 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 peptides vaccine. Also we evaluate the immunological and clinical response of this vaccine therapy.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1	CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-06-01
• Completion: 2014-11-01
• First posted: 2010-12-14
• Last updated: 2014-11-17

Locations

1 site across 1 country: Japan