Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer

This study is currently recruiting participants.

Verified June 2012 by Tokyo Medical University

Sponsor:

Collaborators:

Tokyo University

Saint Luca International Hospital

Information provided by (Responsible Party):

Minoru Fujimori, Tokyo Medical University

ClinicalTrials.gov Identifier:

NCT01259505

First received: December 11, 2010

Last updated: June 27, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 11, 2010
Last Updated Date	June 27, 2012
Start Date ^ICMJE	December 2009
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2010)	safety (Phase I: toxicities as assessed by NCI CTCAE version3) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01259505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 13, 2010)	to evaluate efficacy (feasibility as evaluated by RECIST) [ Time Frame: 2 months ] [ Designated as safety issue: No ] 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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer
Official Title ^ICMJE	Phase I Study of Multiple-Vaccine Therapy Using Epitope Peptides Restricted to HLA-A*2402 in Treating Patients With Refractory Breast Cancer
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Metastatic Breast Cancer
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 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. Intervention: Biological: CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	9
Estimated Completion Date	December 2012
Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01259505
Other Study ID Numbers ^ICMJE	MBCCTA-001-STT
Has Data Monitoring Committee	Yes
Responsible Party	Minoru Fujimori, Tokyo Medical University
Study Sponsor ^ICMJE	Tokyo Medical University
Collaborators ^ICMJE	Tokyo University Saint Luca International Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	Tokyo Medical University
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top