Status:
UNKNOWN
PhaseⅠ/Ⅱ Study of URLC10-177 and TTK-567 Peptide Vaccine Combined With CpG7909 in Patients With Esophageal Cancer
Lead Sponsor:
Wakayama Medical University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single institution phase I / II trial to evaluate the safety and efficacy of URLC10-177 and TTK-567 emulsified with Montanide ISA 51 in combination with different doses of CpG7909 in patient...
Detailed Description
phase I: Patients will be vaccinated on day 1,8,15 and 22 of each 28-day treatment cycles. On each vaccination day, the URLC10-117 peptide(1mg) and TTK-567 peptide(1mg) mixed with CpG 7909 (escalating...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer
- measurable disease by CT scan
- PATIENT CHARACTERISTICS
- ECOG performance status 0-1
- Life expectancy \> 3 months
- Laboratory values as follows
- 2000/mm3 \< WBC \< 15000/mm3
- Platelet count \> 75000/mm3
- Aspartate transaminase \< 150 IU/L
- Alanine transaminase \< 150 IU/L
- Creatinine \< 2.0 mg/dl
- HLA-A\*2402
- 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
- Concurrent treatment with steroids or immunosuppressing agent
- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- Clinically significant heart disease
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00669292
Start Date
November 1 2006
Last Update
September 9 2010
Active Locations (1)
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1
Wakayama Medical University Hospital
811-1 Kimiidera, Wakayama, Wakayama, Japan