Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

Phase 1

Withdrawn

• Conditions: Pancreatic Cancer

• Registration Number: NCT00027521
• Lead Sponsor: Ichor Medical Systems Incorporated

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-12-07
• Study First Submitted QC: 2003-11-20
• Study First Posted: 2003-11-21
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified