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Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00027521
Recruitment Status : Withdrawn (Program terminated)
First Posted : November 21, 2003
Last Update Posted : September 19, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Ichor Medical Systems Incorporated

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: bleomycin sulfate Drug: electroporation therapy Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
Study Start Date : December 2000

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027521


Sponsors and Collaborators
Ichor Medical Systems Incorporated
National Cancer Institute (NCI)
Investigators
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Study Chair: Richard C. Karl, MD H. Lee Moffitt Cancer Center and Research Institute
More Information
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ClinicalTrials.gov Identifier: NCT00027521    
Other Study ID Numbers: CDR0000069037
ICHOR-MCC-12305
MCC-12305
MCC-IRB-5948
NCI-V01-1672
First Posted: November 21, 2003    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012
Keywords provided by Ichor Medical Systems Incorporated:
stage III pancreatic cancer
adenocarcinoma of the pancreas
Additional relevant MeSH terms:
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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