Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

NCT ID: NCT01259505

Last Updated: 2014-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Safety

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.

Group Type: EXPERIMENTAL

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Advanced or recurrent breast cancer
• Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
• Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
• 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, or immunotherapy within 4 weeks
• Decision of unsuitableness by principal investigator or physician-in-charge

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo University

OTHER

Sponsor Role: collaborator

Saint Luca International Hospital

UNKNOWN

Sponsor Role: collaborator

Tokyo Medical University

OTHER

Sponsor Role: lead

Responsible Party

Minoru Fujimori

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tokyo Medical University Ibaraki Medical Center

Ami Inashiki, Ibaraki, Japan

Countries

Japan

Other Identifiers

MBCCTA-001-STT

Identifier Type: -

Identifier Source: org_study_id