Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281736
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2006-01-24
Brief Title:
Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barretts Esophagus Randomization to Two PDT Treatment Regimens of HPPH 2-1 Hexyloxyethyl-2devinylpyropheophorbide-a and Light
Status:
COMPLETED
Status Verified Date:
2013-12
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 such as HPPH that is absorbed by tumor cells The drug becomes active when it is exposed to light and kills tumor cells HPPH may be effective in killing precancerous cells and tumor cells
PURPOSE This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer
PURPOSE This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer
Detailed Description:
OBJECTIVES
Determine response in patients with high-grade dysplasia carcinoma in situ or early intramucosal adenocarcinoma of the esophagus and Barretts esophagus treated with photodynamic therapy using HPPH
Determine the safety in terms of toxicity to surrounding normal tissue of this regimen in these patients
Determine the toxic effects of this regimen on surrounding normal tissue in these patients
Determine the incidence of adenocarcinoma in these patients after this treatment
Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen
Determine the minimal erythemal dose of this regimen in these patients
OUTLINE This is a randomized study Patients are stratified according to presence of intramucosal tumor yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive HPPH IV over 1 hour on day 1 Approximately 24 hours later the lesion is exposed to laser light endoscopically
Arm II Patients receive HPPH as in arm I but at a higher dose followed by laser light exposure
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study within 3 years
Determine response in patients with high-grade dysplasia carcinoma in situ or early intramucosal adenocarcinoma of the esophagus and Barretts esophagus treated with photodynamic therapy using HPPH
Determine the safety in terms of toxicity to surrounding normal tissue of this regimen in these patients
Determine the toxic effects of this regimen on surrounding normal tissue in these patients
Determine the incidence of adenocarcinoma in these patients after this treatment
Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen
Determine the minimal erythemal dose of this regimen in these patients
OUTLINE This is a randomized study Patients are stratified according to presence of intramucosal tumor yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive HPPH IV over 1 hour on day 1 Approximately 24 hours later the lesion is exposed to laser light endoscopically
Arm II Patients receive HPPH as in arm I but at a higher dose followed by laser light exposure
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm 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 |
|---|---|---|---|
| I 30404 | OTHER | Roswell Park Cancer Institute | None |