This trial is active, not recruiting.

Condition pancreatic cancer
Treatments vegfr1, vegfr2, gemcitabine
Phase phase 1
Sponsor Fukushima Medical University
Collaborator Human Genome Center, Institute of Medical Science, University of Tokyo
Start date April 2008
End date March 2010
Trial size 6 participants
Trial identifier NCT01266720, 689


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Interventions: Biological: VEGFR1, VEGFR2 Drug: Gemcitabine
vegfr1, vegfr2 VEGFR1 and VEGFR2 specific epitope vaccine
One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22
gemcitabine Gemzar
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.

Primary Outcomes

Toxicities as assessed by NCI-CACAE ver3
time frame: 3 months

Secondary Outcomes

Differences of peptide specific CTL response in vitro among sequence of gemcitabine and peptide vaccine administration
time frame: 3 months
CD8 population
time frame: 3 months
Change in level of regulatory T cells
time frame: 3 months
Objective response rate
time frame: 1 year
time frame: 1 year
time frame: 1 year

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Phase 1 Study of HLA-A*0201 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Fukushima Medical University.