Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453336
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2007-03-27
Brief Title:
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions Cancer or Other Disease of the Aerodigestive Tract
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium Photofrin for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract
Status:
COMPLETED
Status Verified Date:
2016-12
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 a drug that becomes active when it is exposed to a certain kind of light When the drug is active precancerous cells and cancer cells are killed
PURPOSE This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions cancer or other disease of the aerodigestive tract
PURPOSE This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions cancer or other disease of the aerodigestive tract
Detailed Description:
OBJECTIVES
Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions carcinoma in situ select superficial squamous cell carcinoma of the oral cavity oropharynx or larynx or condemned mucosa syndrome in the upper aerodigestive tract
Determine the safety of this regimen in these patients
OUTLINE Patients are stratified according to disease condition benign vs malignant
Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4
After completion of study treatment patients are followed at 3 and 4 months and then periodically for up to 2 years
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions carcinoma in situ select superficial squamous cell carcinoma of the oral cavity oropharynx or larynx or condemned mucosa syndrome in the upper aerodigestive tract
Determine the safety of this regimen in these patients
OUTLINE Patients are stratified according to disease condition benign vs malignant
Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4
After completion of study treatment patients are followed at 3 and 4 months and then periodically for up to 2 years
PROJECTED ACCRUAL A total of 47 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 |
|---|---|---|---|
| WIRB-20050715 | OTHER | Western Institutional Review Board | None |
| SCCC-2002103 | OTHER | None | None |