Barrett's Esophagus Clinical Trial
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
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 2013 |
Est. primary completion date | May 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park cancer institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity of HPPH at different doses | 2 days | Yes | |
Secondary | 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 | No |
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