Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

February 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Drug: porfimer sodium
Other: fluorophotometry

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002964

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065455, RPCI-DS-94-10, NCI-V97-1196

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Wesley L. Hicks, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2001

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