Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer

OBJECTIVES:

• Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's esophagus treated with photodynamic therapy using HPPH.
• Determine the safety, in terms of toxicity to surrounding normal tissue, of this regimen in these patients.
• Determine the toxic effects of this regimen on surrounding normal tissue in these patients.
• Determine the incidence of adenocarcinoma in these patients after this treatment.
• Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen.
• Determine the minimal erythemal dose of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to presence of intramucosal tumor (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
• Arm II: Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study within 3 years.

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