Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054002
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2003-02-05
Brief Title:
Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Surgery and Intracavitary Photodynamic Therapy PDT for the Treatment of Malignant Pleural Mesothelioma The Use of Light Delivery Fibers With Large Diffusers
Status:
COMPLETED
Status Verified Date:
2011-02
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 cancer cells Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma
PURPOSE Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma
PURPOSE Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma
Detailed Description:
OBJECTIVES
Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery
Compare results of this regimen in these patients to historical controls
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study
Patients receive porfimer sodium IV over 5-10 minutes on day 1 Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3
Patients are followed at 1 month every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 3 years
Determine the feasibility of adjuvant photodynamic therapy with large diffuser fibers in patients with malignant mesothelioma undergoing surgery
Compare results of this regimen in these patients to historical controls
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study
Patients receive porfimer sodium IV over 5-10 minutes on day 1 Patients undergo pleurectomy or pleuropneumonectomy followed by intracavitary photodynamic therapy on day 3
Patients are followed at 1 month every 4 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| RPCI-RP-9812 | None | None | None |