HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

• Status: Unknown status
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fukushima Medical University
• Collaborator: Human Genome Center, Institute of Medical Science, University of Tokyo
• Treatments: Gemcitabine; Vaccines

Criteria

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