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

NCT ID: NCT01236443

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2013-04-30

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.

Conditions

Barrett's Esophagus; CIS; High Grade Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HPPH

3 mg/m2

Group Type: EXPERIMENTAL

HPPH

Intervention Type: DRUG

3 mg/m2 IV

Interventions

HPPH

3 mg/m2 IV

Intervention Type: DRUG

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-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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hector Nava, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park cancer institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RP 00-02

Identifier Type: -

Identifier Source: org_study_id