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Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer Clinical research trials and Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer  Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ichor Medical Systems Incorporated
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardKarl, Study Chair, Ichor Medical Systems Incorporated
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Additional Information:
Study ID Numbers: CDR0000069037; ICHOR-MCC-12305,NCI-V01-1672,MCC-12305,MCC-IRB-5948
Study Start Date: February 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027521
Other Stage 3 Pancreatic Cancer Studies:
1. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
2. Biological Therapy in Treating Patients With Stage I, Stage II, or Stage III Pancreatic Cancer That Has Been Surgically Removed
3. Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
4. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
5. Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
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