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Home > "P" Clinical Trials Conditions > Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer  Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
For Condition: stage 0 lip and oral cavity cancer,stage 1 hypopharyngeal cancer,stage 0 hypopharyngeal cancer,stage 1 oropharyngeal cancer,stage 0 oropharyngeal cancer,stage 1 lip and oral cavity cancer,stage 0 laryngeal cancer,stage 1 laryngeal cancer
Status: Completed
Sponsor(s): Roswell Park Cancer Institute ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --Prior/Concurrent Therapy-- - Not specified --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WesleyHicks, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000065455; RPCI-DS-94-10,NCI-V97-1196
Study Start Date: February 1995
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002964
Other Stage 0 Oropharyngeal Cancer Studies:
1. Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
2. Dentures and Dental Implants in Treating Patients Undergoing Surgery for Mouth Cancer
Related Studies:
Other stage 0 oropharyngeal cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
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