- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002964
Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
PRIOR CONCURRENT THERAPY: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Wesley L. Hicks, MD, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS 94-10
- RPCI-DS-94-10
- NCI-V97-1196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on porfimer sodium
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Head and Neck Carcinoma | Locally Advanced Head and Neck CarcinomaUnited States
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Roswell Park Cancer InstituteCompletedEsophageal CancerUnited States
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Ohio State University Comprehensive Cancer CenterCompleted
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Concordia Laboratories Inc.CompletedNon-small Cell Lung Cancer (NSCLC) | Lung MetastasisUnited States, Canada
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Concordia Laboratories Inc.Completed
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedPancreatic Cancer | Liver Cancer | Gallbladder Cancer | Extrahepatic Bile Duct CancerUnited States
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University College, LondonCompletedGallbladder Cancer | Extrahepatic Bile Duct CancerUnited Kingdom
-
Harry T Whelan, MDPinnacle Biologics Inc.CompletedBrain Tumor, RecurrentUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed
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Roswell Park Cancer InstituteTerminated