NCT00060268

Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	HPPH	iv

Timeline

• Start date: 1997-01-01
• Primary completion: 2003-09-01
• Completion: 2004-06-01
• First posted: 2003-05-07
• Last updated: 2011-03-09

Locations

1 site across 1 country: United States