Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with
bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and
progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15
minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes.
Approximately 5 minutes after the IV injection, patients undergo electroporation therapy
comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are
followed weekly for 4-6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18
months.
Interventional
Primary Purpose: Treatment
Richard C. Karl, MD
Study Chair
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
CDR0000069037
NCT00027521
December 2000
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