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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002964 |
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 II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light |
| Study Start Date: | February 1995 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Wesley L. Hicks, MD | Roswell Park Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00002964 History of Changes |
| Other Study ID Numbers: | CDR0000065455, RPCI-DS-94-10, NCI-V97-1196 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Trioxsalen Dihematoporphyrin Ether Photosensitizing Agents |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Antineoplastic Agents |
