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Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002964
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : February 5, 2013
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: porfimer sodium Other: fluorophotometry Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
Study Start Date : February 1995
Actual Primary Completion Date : April 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth, oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or invasive carcinoma of the head and neck

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity to porphyrins Not pregnant Fertile patients must use effective birth control


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002964

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Study Chair: Wesley L. Hicks, MD Roswell Park Cancer Institute
Layout table for additonal information Identifier: NCT00002964    
Other Study ID Numbers: DS 94-10
First Posted: April 27, 2004    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Roswell Park Cancer Institute:
stage 0 oropharyngeal cancer
stage 0 laryngeal cancer
stage 0 hypopharyngeal cancer
stage 0 lip and oral cavity cancer
stage I lip and oral cavity cancer
stage I hypopharyngeal cancer
stage I laryngeal cancer
stage I oropharyngeal cancer
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Dihematoporphyrin Ether
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents