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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute

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