Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027521
Status:
WITHDRAWN
Last Update Posted:
2012-09-19
First Post:
2001-12-07
Brief Title:
Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
Sponsor:
Ichor Medical Systems Incorporated
Organization:
Ichor Medical Systems Incorporated
Study Overview
Official Title:
Phase I Study Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Program terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICHOR-MCC-12305 | None | None | None |
| MCC-12305 | None | None | None |
| MCC-IRB-5948 | None | None | None |
| NCI-V01-1672 | None | None | None |