Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
Information source: Ichor Medical Systems Incorporated
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: bleomycin sulfate (Biological); electroporation therapy (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Ichor Medical Systems Incorporated Official(s) and/or principal investigator(s): Richard C. Karl, MD, Study Chair, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
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.
Clinical Details
Official title: Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
Study design: Primary Purpose: Treatment
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2000
Last updated: September 17, 2012
|