Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer
NCT ID: NCT00677612
Last Updated: 2009-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2008-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy.
Interventions
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VEGFR1 and VEGFR2
Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
85 Years
ALL
No
Sponsors
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Human Genome Center, Institute of Medical Science, University of Tokyo
OTHER
Tokyo University
OTHER
Responsible Party
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The Institute of Medical Science, The University of Tokyo
Principal Investigators
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Masaru Shinozaki, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Head, Department of Surgery
Locations
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The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan
Countries
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References
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Li Y, Wang MN, Li H, King KD, Bassi R, Sun H, Santiago A, Hooper AT, Bohlen P, Hicklin DJ. Active immunization against the vascular endothelial growth factor receptor flk1 inhibits tumor angiogenesis and metastasis. J Exp Med. 2002 Jun 17;195(12):1575-84. doi: 10.1084/jem.20020072.
Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
Related Links
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Research Hospital, the Institute of Medical Science, the University of Tokyo
Other Identifiers
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CRC-A02-I, II
Identifier Type: -
Identifier Source: org_study_id