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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-DS-94-10 | |||
| NCI-V97-1196 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| porfimer sodium | Drug | |||
| fluorophotometry | Other |
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
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| Name | Affiliation | Role |
|---|---|---|
| Wesley L. Hicks, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
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| ID | Term |
|---|---|
| D017323 | Dihematoporphyrin Ether |
| D015590 | Fluorophotometry |
| ID | Term |
|---|---|
| D017324 | Hematoporphyrin Derivative |
| D006415 | Hematoporphyrins |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
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| D010608 |
| Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |