Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer.
PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.
|Head and Neck Cancer||Drug: porfimer sodium Other: fluorophotometry||Phase 2|
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light|
|Study Start Date:||February 1995|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage.
OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days.
PROJECTED ACCRUAL: 20 patients will be accrued per year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002964
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Wesley L. Hicks, MD||Roswell Park Cancer Institute|