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| ID | Type | Description | Link |
|---|---|---|---|
| I 30404 | Other Identifier | Roswell Park Cancer Institute |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically. |
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| Arm II | Experimental | Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPPH | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 3 years | |
| Response | 3 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus
Diagnosis of Barrett's esophagus
Ineligible for or refused surgical resection
Requires endoscopy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Hector R. Nava, MD, FACS | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D011230 | Precancerous Conditions |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C083998 | 2-(1-hexyloxyethyl)-2-devinyl pyropheophorbide-a |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |