Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer. PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.


Study summary:

OBJECTIVES: Primary - To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx. Secondary - To determine response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of laser light therapy. Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.


Criteria:

DISEASE CHARACTERISTICS: - Biopsy-confirmed diagnosis of 1 of the following: - Mild to severe dysplasia of the larynx - Dysplastic lesions > 3 mm in thickness - Squamous cell carcinoma in situ of the larynx - T1 squamous cell carcinoma of the larynx - Tumor > 3 mm in thickness - No T2-T4 squamous cell carcinoma of the larynx - Newly diagnosed or recurrent disease PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Total bilirubin > 2.0 mg/dL - Creatinine > 2.0 mg/dL - SGOT > 3 times upper limit of normal (ULN) - Alkaline phosphatase > 3 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment - No porphyria - No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: - Any prior therapy allowed - At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy


NCT ID:

NCT00675233


Primary Contact:

Principal Investigator
Hassan Arshad, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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