Status:
COMPLETED
Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Barrett's Esophagus
CIS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01236443
Start Date
August 1 2000
End Date
April 1 2013
Last Update
January 13 2014
Active Locations (1)
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1
Roswell Park cancer institute
Buffalo, New York, United States, 14263