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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Efficacy
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
Intervention: HPPH (Drug)
Arm II
Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
Intervention: HPPH (Drug)
Outcomes
Primary Outcomes
Efficacy
Time Frame: 3 years
Secondary Outcomes
- Toxicity(3 years)
- Response(3 years)