Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003923
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
1999-11-01
Brief Title:
Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct Gallbladder or Pancreas
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Photodynamic Therapy With PHOTOFRIN Porfimer Sodium for Injection in Patients With Malignant Bile Duct Obstruction
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells This may be effective treatment for cancer of the bile duct gallbladder or pancreas
PURPOSE Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct gallbladder or pancreas
PURPOSE Phase II trial to determine the effectiveness of photodynamic therapy in treating patients who have cancer of the bile duct gallbladder or pancreas
Detailed Description:
OBJECTIVES I Determine the safety and efficacy of photodynamic therapy using porfimer sodium in patients with unresectable malignant bile duct obstruction
OUTLINE Patients are stratified according to tumor location proximal vs distal Patients receive porfimer sodium IV over 3-5 minutes on day 1 followed by percutaneous or endoscopic laser light treatment on day 3 Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses Patients are followed weekly for 1 month and then monthly for 1 year
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE Patients are stratified according to tumor location proximal vs distal Patients receive porfimer sodium IV over 3-5 minutes on day 1 followed by percutaneous or endoscopic laser light treatment on day 3 Patients achieving partial response or complete response accompanied by an increase in total bilirubin or cholangitis may repeat treatment for a maximum of 3 courses Patients are followed weekly for 1 month and then monthly for 1 year
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-99015 | None | None | None |
| NCI-G99-1525 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |