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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light

Conditions
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Esophageal Cancer, Precancerous Condition

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically. | Drug: HPPH<br>* Given IV<br>|
| Experimental: Arm II<br>Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure. | Drug: HPPH<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 3 years | 
| Response |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the esophagus, recurrent esophageal cancer, stage 0 esophageal cancer, stage I esophageal cancer, precancerous condition