Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259505
• Other study ID #: MBCCTA-001-STT
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2010
• Last updated: November 13, 2014
• Start date: December 2009
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Tokyo Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Japan	Tokyo Medical University Ibaraki Medical Center	Ami Inashiki	Ibaraki

Sponsors (3)

Lead Sponsor	Collaborator
Tokyo Medical University	Saint Luca International Hospital, Tokyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety (Phase I: toxicities as assessed by NCI CTCAE version3)		1 month	Yes
Secondary	to evaluate efficacy (feasibility as evaluated by RECIST)	to evaluate overall survival to evaluate progression free survivial to evaluate efficacy (feasibility as evaluated by RECIST) to evaluate immunological responses to evaluate quality of life	2 months	No