Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer.
Biological: bleomycin sulfate
Drug: electroporation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer|
|Study Start Date:||December 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027521
|Study Chair:||Richard C. Karl, MD||H. Lee Moffitt Cancer Center and Research Institute|