Esophageal Cancer Clinical Trial
Official title:
A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to
light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells
and, when exposed to light, become active and kill the tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in
treating patients who have obstructive esophageal tumors.
OBJECTIVES:
- Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal
tumors undergoing photodynamic therapy.
- Determine, preliminarily, tumor response in patients treated with this drug.
- Determine the length of time for cutaneous photosensitivity at the various drug doses
in these patients.
- Determine plasma clearance rates for this drug in these patients.
OUTLINE: This is a dose-escalation study.
- Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser
light therapy on day 2.
Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the
optimal dose is determined. The optimal dose is defined as the minimum dose producing
efficacy without unacceptable toxicity.
- Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are
followed monthly for 6-24 months.
PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
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