Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer

Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002964

Enrollment

Unknown

Registered

2004-04-27

Start date

1995-02-28

Completion date

Unknown

Last updated

2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

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

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.

Interventions

DRUGporfimer sodium

OTHERfluorophotometry

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026