Status:
TERMINATED
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer
Lead Sponsor:
Tokyo University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Colorectal Cancer
Colon 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 peptides RNF43, TOMM34, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination ...
Detailed Description
RNF43 and TOMM34 have been identified as cancer specific molecules especially in colorectal cancer using genome-wide expression profile analysis by cDNA microarray technique. VEGF receptor 1 and 2 are...
Eligibility Criteria
Inclusion
- Advanced or recurrent colorectal cancer
- Resistant against chemotherapy including CPT-11, l-OHP、+/- 5-FU +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s)
- 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 to receive oral Tegafur/Uracil/Folinate therapy
- 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 lesion(s)
- History of allergy to Tegafur, Uracil, and/or Folinate
- 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
NCT00677287
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