Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be an effective palliative treatment for head and neck cancer.
PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy for palliative treatment in patients who have recurrent, refractory, or second primary head and neck cancer that cannot be treated with surgery or radiation therapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multicenter, Multi-National, Open-Label, Single Group, Single and Multiple Dose Study of Foscan-Mediated Photodynamic Therapy (PDT) for the Palliative Treatment of Recurrent, Refractory or Second Primary Squamous Cell Carcinomas of the Head and Neck in Patients Considered to be Incurable With Surgery or Radiotherapy|
|Study Start Date:||October 1998|
OBJECTIVES: I. Determine the individual clinical benefit of temoporfin-mediated photodynamic therapy for palliative treatment in patients with recurrent, refractory, or second primary squamous cell cancer of the head and neck. II. Determine the improvement in global, functional, and symptomatic measures of quality of life in these patients. III. Determine the toxic effects, tolerability, and safety of this regimen in these patients. IV. Determine the population pharmacokinetics, objective tumor response (complete and partial), and the 1 year survival of these patients on this regimen.
OUTLINE: This is a multicenter study. Patients receive IV temoporfin on day -4, followed by laser light therapy on day 0. Patients are treated every 4 to 16 weeks for a maximum of 3 courses. Patients are evaluated on days 1, 2, 7, and weeks 2, 4, 6, 8, 12, and 16 following laser light therapy. Quality of life is assessed at baseline through week 12 of follow-up. Patients are followed monthly for 4 months after the final treatment, then every 3 months for 1 year.
PROJECTED ACCRUAL: A minimum of 50 prospective and 25 retrospective patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003856
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Division of Head and Neck Surgery|
|Evanston, Illinois, United States, 60201|
|United States, Kentucky|
|Norton Healthcare Pavilion|
|Louisville, Kentucky, United States, 40202|
|United States, Minnesota|
|Ear, Nose, and Throat Specialty Care of Minnesota, P.A.|
|Minneapolis, Minnesota, United States, 55404|
|United States, New York|
|School of Dental Medicine|
|Buffalo, New York, United States, 14214-3008|
|St. Luke's-Roosevelt Hospital|
|New York, New York, United States, 10019|
|Study Chair:||Barbara Larson||Quintiles, Inc.|