Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
Esophageal Cancer, Precancerous Condition
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, recurrent esophageal cancer, stage 0 esophageal cancer, stage I esophageal cancer, precancerous condition
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus Stage 0 or N0, M0 primary or recurrent disease Diagnosis of Barrett's esophagus Ineligible for or refused surgical resection Requires endoscopy PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 50-100% Life expectancy Not specified Hematopoietic WBC ≥ 4,000/mm^3 Platelet count ≥ 100,000/mm^3 PT ≤ 1.5 times upper limit of normal (ULN) Hepatic Bilirubin ≤ 2.0 mg/dL Alkaline phosphatase ≤ 3 times ULN ALT ≤ 3 times ULN Renal Creatinine ≤ 2 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment No contraindication to endoscopy No other malignancy except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Chemotherapy At least 1 month since prior chemotherapy No concurrent chemotherapy Radiotherapy At least 1 month since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics Other At least 1 month since prior Nd-YAG laser therapy At least 4 weeks since prior therapy for this disease
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.