Status:
COMPLETED
Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer
Lead Sponsor:
Wakayama Medical University
Collaborating Sponsors:
Human Genome Center, Institute of Medical Science, University of Tokyo
Conditions:
Pancreatic 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 VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine...
Detailed Description
Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
- measurable disease by CT scan
- PATIENT CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Laboratory values as follows
- 2000/mm3 \< WBC \< 15000/mm3
- Platelet count \> 75000/mm3
- Bilirubin \< 3.0 mg/dl
- Aspartate transaminase \< 150 IU/L
- Alanine transaminase \< 150 IU/L
- Creatinine \< 3.0 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 of gemcitabine
- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
- Serious or nonhealing wound, ulcer, or bone fracture
- Active or uncontrolled other malignancy
- Ileus
- Interstitial pneumonia
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00622622
Start Date
November 1 2006
End Date
February 1 2009
Last Update
February 18 2009
Active Locations (1)
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1
Wakayama Medical University Hospital
811-1 Kimiidera, Wakayama, Wakayama, Japan