Status:
SUSPENDED
Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer
Lead Sponsor:
Akita University Hospital
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Bile Duct Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immune response of different doses of URLC10 peptide emulsified with Montanide ISA51 in combination with gemcitabine. Recommended...
Detailed Description
Our previous studies have demonstrated that up-regulated lung cancer 10 (URLC10) has been identified as a new target of tumor associated antigen using cDNA microarray technique combined with the expre...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- Advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer
- measurable disease by CT scan, ultrasonography, or other imaging modalities.
- PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy \>3 months
- Laboratory values as follows 2,000/mm³\< WBC \< 15,000/mm³ Platelet count ≥ 75,000/mm³ Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper limits
- HLA-A\*2402 or HLA-A\*0201
- 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
- Serious or uncontrolled infection
- Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks.
- Other malignancy within 5 years prior to entry into the study
- Concomitant treatment with steroids or immunosuppressing agent
- 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 :
December 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00624182
Start Date
February 1 2008
End Date
December 1 2016
Last Update
June 23 2015
Active Locations (1)
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1
Akita University Hosipital
Akita, Akita, Japan, 010-8543