Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus
- Registration Number
- NCT01236443
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HPPH HPPH 3 mg/m2
- Primary Outcome Measures
Name Time Method Toxicity of HPPH at different doses 2 days
- Secondary Outcome Measures
Name Time Method Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus length of study Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
Trial Locations
- Locations (1)
Roswell Park cancer institute
🇺🇸Buffalo, New York, United States