Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors

Study Overview
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Brief Summary
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RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.

Detailed Description
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OBJECTIVES: Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy. Determine, preliminarily, tumor response in patients treated with this drug. Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients. Determine plasma clearance rates for this drug in these patients. OUTLINE: This is a dose-escalation study. Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2. Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity. Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months. PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.

Official Title
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A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: HPPH


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed esophageal cancer Stages T1-T3, any N, any M Tumor partially or completely obstructing the esophagus Primary or recurrent tumor meeting 1 of the following criteria for treatment: Patient is too debilitated for or refused conventional therapy Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site No tracheal or bronchial involvement by bronchoscopy No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic Bilirubin no greater than 3.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN PT no greater than 1.5 times ULN Renal Creatinine no greater than 3.0 mg/dL Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No contraindications to endoscopy No porphyria No hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HPPH|iv|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer