Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus

January 10, 2014 updated by: Roswell Park Cancer Institute

A Phase I/II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2-devinylpyropheophorbide-a (HPPH) for the Treatment of High Grade Dysplasia, Carcinoma-in-situ and Early Adenocarcinoma in Barrett's Esophagus

A Study to identify toxicity and optimal photodynamic treatment parameters using the photosensitizer 2-[1-hydroxyethyl]-2-devinylpyropheophorbide-a (HPPH) in high grade dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have biopsy proven high-grade (severe) dysplasia, carcinoma-in-situ or early stage adenocarcinoma;
  • Patient may have received prior therapy; e.g. Nd-YAG laser, radiation therapy or chemotherapy. At least one month must have elapsed between prior treatments and PDT.
  • Tumors can be primary or recurrent, Stage 0 or I, N0M (any).
  • Patients must have no contraindications to endoscopy.
  • Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A pregnancy test is required and must be negative.
  • Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB.
  • Patients must have a Karnofsky status 50 or above.
  • Operable patients are not excluded.

Exclusion Criteria:

  • Patients with tumors of grade greater than T-1.
  • Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
  • WBC <2,000; platelet count <50,000, prothrombin time 1.5 times above the upper normal limit.
  • Patients with impaired renal and/or hepatic function (total serum bilirubin >3.0 mg/d, serum creatinine >3 mg%, alkaline phosphatase (hepatic) or SGOT >3 times the upper normal limit.
  • Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
  • If the patient has cancer other than non-melanoma skin cancer they must be deemed disease free by their treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPPH
3 mg/m2
Drug: HPPH
3 mg/m2 IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity of HPPH at different doses
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
Time Frame: length of study
Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Hector Nava, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 8, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 00-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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