Esophageal Cancer, Precancerous Condition
Conditions
Keywords
adenocarcinoma of the esophagus, recurrent esophageal cancer, stage 0 esophageal cancer, stage I esophageal cancer, precancerous condition
Brief 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.
Detailed description
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.
Interventions
DRUGHPPH
Given IV
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 3 years |
| Response | 3 years |
Countries
United States
Outcome results
None listed