Status:
UNKNOWN
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Tokyo University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Non Small Cell Lung 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\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
Detailed Description
URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-...
Eligibility Criteria
Inclusion
- Disease characteristics
- Advanced or recurrent non small cell lung cancer
- Second line or later therapeutic status Patient characteristics
- ECOG performance status 0-2
- Life expectancy \> 3 months
- HLA-A\*0201
- 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
- Unhealed external wound
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- Uncontrolled brain and/or intraspinal metastasis
- 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 :
April 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00673777
Start Date
May 1 2008
End Date
April 1 2009
Last Update
May 14 2008
Active Locations (1)
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1
The Institute of Medical Science, The University of Tokyo
Tokyo, Tokyo, Japan, 108-8639