Esophageal Cancer Clinical Trial
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
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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