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

Roswell Park Cancer Institute1 site in 1 country18 target enrollmentAugust 2000

ConditionsBarrett's Esophagus CIS High Grade Dysplasia

InterventionsHPPH

DrugsHPPH

Overview

Phase: Phase 1
Intervention: HPPH
Conditions: Barrett's Esophagus
Sponsor: Roswell Park Cancer Institute
Enrollment: 18
Locations: 1
Primary Endpoint: Toxicity of HPPH at different doses
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2000

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Roswell Park Cancer Institute

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.