Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
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.
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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)|
|Study Start Date:||January 1997|
|Study Completion Date:||June 2004|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060268
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Hector R. Nava, MD, FACS||Roswell Park Cancer Institute|