Status:
TERMINATED
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer
Lead Sponsor:
Tokyo University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Breast Cancer
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptide TTK emulsified with Montanide ISA 51.
Detailed Description
TTK has 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 restrict...
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
- Uncontrolled brain and/or intraspinal
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00678509
Start Date
May 1 2008
End Date
March 1 2009
Last Update
December 29 2009
Active Locations (1)
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1
The Institute of Medical Science, the University of Tokyo
Minato-ku, Tokyo, Japan, 108-8639