Status:
COMPLETED
Safety Study of Multiple-Vaccine to Treat Metastatic Breast Cancer
Lead Sponsor:
Tokyo Medical University
Collaborating Sponsors:
Tokyo University
Saint Luca International Hospital
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01259505
Start Date
December 1 2009
End Date
November 1 2014
Last Update
November 17 2014
Active Locations (1)
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1
Tokyo Medical University Ibaraki Medical Center
Ami Inashiki, Ibaraki, Japan, 300-0395