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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

CIS

High Grade Dysplasia

Barrett's Esophagus

Treatments

Drug: HPPH

Study type

Interventional

Funder types

Other

Identifiers

NCT01236443

RP 00-02

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.