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Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002964
First Posted: April 27, 2004
Last Update Posted: February 5, 2013
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.
Information provided by:
Roswell Park Cancer Institute
  Purpose

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 Intervention Phase
Head and Neck Cancer Drug: porfimer sodium Other: fluorophotometry Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: February 1995
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00002964


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Wesley L. Hicks, MD Roswell Park Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00002964     History of Changes
Other Study ID Numbers: DS 94-10
RPCI-DS-94-10
NCI-V97-1196
First Submitted: November 1, 1999
First Posted: April 27, 2004
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:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Dihematoporphyrin Ether
Trioxsalen
Antineoplastic Agents
Dermatologic Agents
Photosensitizing Agents