Status:
UNKNOWN
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer
Lead Sponsor:
Fukushima 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, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine
Detailed Description
Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce th...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS
- 1\. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. Measurable disease by CT scan PATIENTS CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Laboratory values as follows 2,000/mm3 \< WBC \< 15000/mm3 Platelet count ≥ 750,000/mm³ Total Bilirubin ≤ 1.5 x 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 (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breast-feeder
- Active or uncontrolled infection
- Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
- Serious or aggravated wound
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependant status
- Interstitial pneumonia
- Ileus
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00639925
Start Date
March 1 2007
End Date
March 1 2013
Last Update
March 14 2013
Active Locations (1)
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1
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan