HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)
- Registration Number
- NCT01266720
- Lead Sponsor
- Fukushima Medical University
- Brief Summary
The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.
- Detailed Description
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
- Measurable disease by CT scan
- 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, Total Bilirubin <1.5 mg/dl, Asparate transaminase <150IU/L, Alanine transaminase < 150 IU/L, Creatinine < 3.0mg/dl
- HLA-A*0201
- Able and willing to give valid written infromed consent
Exclusion Criteria
- 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 uncured wound
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependent status
- Interstitial pneumonia
- Ileus
- Decision of unsuitableness by principal investigator or physician-in-charge
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 1 study VEGFR1, VEGFR2 Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine Phase 1 study Gemcitabine Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
- Primary Outcome Measures
Name Time Method Toxicities as assessed by NCI-CACAE ver3 3 months
- Secondary Outcome Measures
Name Time Method Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration 3 months CD8 population 3 months Change in level of regulatory T cells 3 months Feasibility 1 year Survival 1 year Objective response rate 1 year
Trial Locations
- Locations (1)
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan