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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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CIS, Barrett's Esophagus, High Grade Dysplasia

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPPH<br>3 mg/m2 | Drug: HPPH<br>* 3 mg/m2 IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of HPPH at different doses |  | 2 days | 

Secondary Outcome Measures

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