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Sponsored by: |
Roswell Park Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00281736 |
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.
Condition | Intervention | Phase |
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Esophageal Cancer Precancerous/Nonmalignant Condition |
Drug: HPPH |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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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Drug: HPPH
Given IV
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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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Drug: HPPH
Given IV
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Hector R. Nava, MD, FACS | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Hector R. Nava ) |
Study ID Numbers: | CDR0000441205, RPCI-I-30404 |
Study First Received: | January 24, 2006 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00281736 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the esophagus recurrent esophageal cancer stage 0 esophageal cancer stage I esophageal cancer precancerous/nonmalignant condition |
Digestive System Neoplasms Precancerous Conditions Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Recurrence Carcinoma Digestive System Diseases |
Barrett Syndrome Esophageal Disorder Carcinoma in Situ Head and Neck Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases Adenocarcinoma |
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Precancerous Conditions |
Gastrointestinal Diseases Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |