Status:
UNKNOWN
Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer
Lead Sponsor:
Teikyo University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CD...
Detailed Description
Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens usin...
Eligibility Criteria
Inclusion
- Patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer.
- measurable disease by CT scan
- ECOG performance status of 0 to 2
- Expected survival of at lease 3months
- Patients must be HLA-A2402
- Laboratory values as follow:
- WBC \> 2000/mm3,
- Platelet count \> 75000/mm3,
- Total bilirubin \< 1.5 x the institutional normal upper limits,
- Creatinine \< 1.5 x the institutional normal upper limits,
- AST. ALT. ALP \< 2.5 x the institutional normal upper limits
- Able and willing to give valid written informed consent
Exclusion
- Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks
- Concurrent treatment with steroid or immunosuppressing agent
- Patient with peptic ulcer disease
- Active or uncontrolled other malignancy
- Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
- Disease to the central nervous system
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00632333
Start Date
February 1 2008
End Date
March 1 2012
Last Update
July 21 2011
Active Locations (1)
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1
Teikyo University
2-11-1 Kaga Itabashi-ku, Tokyo, Japan, 173-0003