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NCT00677612
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer
Archived
Phase 1
Description
The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with Tegafur/Uracil/Folinate chemotherapy.
Documented evidence
Published efficacy for this trial's target/drug in colorectal cancer. It refers to the drug or molecular target, not to this specific trial, and does not confirm eligibility. Always review with your oncologist.
No documented evidence yet in our database for this trial's target or drug. This section grows as new publications are processed.
Eligibility Criteria
Inclusion Criteria:
- 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\*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 to receive oral Tegafur/Uracil/Folinate therapy
- 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
- 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
Trial Information
NCT00677612
Archived
Phase 1
14 participants
May 2008
Locations1
Japan (1)
The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, 108-8639