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Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

2014-07-23 21:52:25 | BioPortfolio

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.

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.

Study Design

Primary Purpose: Treatment

Conditions

Esophageal Cancer

Intervention

HPPH

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263-0001

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:52:25-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the ESOPHAGUS.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

Surgical incision of the lower esophageal sphincter near the CARDIA often used to treat ESOPHAGEAL ACHALASIA.

Circular innermost layer of the ESOPHAGUS wall that mediates esophageal PERISTALSIS which pushes ingested food bolus toward the stomach.

Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).

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