Barrett's Esophagus, CIS, High Grade Dysplasia
Conditions
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.
Interventions
DRUGHPPH
3 mg/m2 IV
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity of HPPH at different doses | 2 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed