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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00675233 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: HPPH Procedure: laser therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-Devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-confirmed diagnosis of 1 of the following:
Mild to severe dysplasia of the larynx
Squamous cell carcinoma in situ of the larynx
T1 squamous cell carcinoma of the larynx
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 |
Principal Investigator: | Nestor R. Rigual, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000595166, RPCI-I-119207 |
Study First Received: | May 8, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00675233 |
Health Authority: | Unspecified |
recurrent squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage 0 laryngeal cancer |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Squamous cell carcinoma Laryngeal Neoplasms Recurrence Carcinoma Epidermoid carcinoma |
Respiratory Tract Diseases Head and Neck Neoplasms Carcinoma in Situ Carcinoma, squamous cell Laryngeal carcinoma Laryngeal Diseases Carcinoma, Squamous Cell |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |