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

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: November 2, 2010
Last updated: January 10, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Barrett's Esophagus
High Grade Dysplasia
Drug: HPPH
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity of HPPH at different doses [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus [ Time Frame: length of study ] [ Designated as safety issue: No ]
    Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus

Enrollment: 18
Study Start Date: August 2000
Study Completion Date: April 2013
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPPH
3 mg/m2
Drug: HPPH
3 mg/m2 IV


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01236443

United States, New York
Roswell Park cancer institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Hector Nava, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01236443     History of Changes
Other Study ID Numbers: RP 00-02
Study First Received: November 2, 2010
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on November 24, 2014