A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)

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.