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| Sponsors and Collaborators: |
Ichor Medical Systems Incorporated National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027521 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer |
| Study Start Date: | December 2000 |
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 |
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| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Study Chair: | Richard C. Karl, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Study ID Numbers: | CDR0000069037, ICHOR-MCC-12305, MCC-12305, MCC-IRB-5948, NCI-V01-1672 |
| Study First Received: | December 7, 2001 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027521 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer adenocarcinoma of the pancreas |
|
Anti-Bacterial Agents Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Adenocarcinoma Pancrelipase Bleomycin Endocrine Gland Neoplasms |
|
Digestive System Neoplasms Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases Antibiotics, Antineoplastic Bleomycin Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Endocrine Gland Neoplasms |