Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light|
- Efficacy [ Time Frame: 3 years ]
- Toxicity [ Time Frame: 3 years ]
- Response [ Time Frame: 3 years ]
|Study Start Date:||February 2004|
|Study Completion Date:||December 2013|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
Experimental: Arm II
Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
- Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281736
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Hector R. Nava, MD, FACS||Roswell Park Cancer Institute|