Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

This study has been withdrawn prior to enrollment.
(Program terminated)
Sponsor:
Collaborator:
Information provided by:
Ichor Medical Systems Incorporated
ClinicalTrials.gov Identifier:
NCT00027521
First received: December 7, 2001
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: bleomycin sulfate
Drug: electroporation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Ichor Medical Systems Incorporated:

Enrollment: 0
Study Start Date: December 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the pancreas Unresectable disease by exploratory laparotomy Involvement of the superior mesenteric artery or occlusion of the superior mesenteric vein-portal vein confluence No extrapancreatic metastases by ultrasound, CT scan, or laparotomy Tumor must be accessible for direct injection of study drug and placement of electrode array

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT no greater than 3 times upper limit of normal No impaired hepatic function Renal: Creatinine no greater than 1.5 mg/dL No impaired renal function Cardiovascular: No impaired cardiac function Pulmonary: No compromised pulmonary function No pulmonary condition that would potentially require the use of high FIO2 levels Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior reaction to bleomycin No fever, infection, or other medical condition that would preclude study Not at high risk for complications associated with abdominal surgery

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior lifetime cumulative dose of bleomycin greater than 400 U Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027521

Sponsors and Collaborators
Ichor Medical Systems Incorporated
Investigators
Study Chair: Richard C. Karl, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00027521     History of Changes
Other Study ID Numbers: CDR0000069037, ICHOR-MCC-12305, MCC-12305, MCC-IRB-5948, NCI-V01-1672
Study First Received: December 7, 2001
Last Updated: September 17, 2012
Health Authority: United States: Federal Government

Keywords provided by Ichor Medical Systems Incorporated:
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014