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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.
 
ClinicalTrials.gov Identifier: NCT00002964
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : February 5, 2013
Sponsor:
Information provided by:
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 27, 2004
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE February 1995
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
Official Title  ICMJE Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Diagnostic
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Drug: porfimer sodium
  • Other: fluorophotometry
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002964
Other Study ID Numbers  ICMJE DS 94-10
RPCI-DS-94-10
NCI-V97-1196
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Wesley L. Hicks, MD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP