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
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.
Primary Purpose: Treatment
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Division of Head and Neck Surgery||Evanston, Illinois 60201|
|Norton Healthcare Pavilion||Louisville, Kentucky 40202|
|Ear, Nose, and Throat Specialty Care of Minnesota, P.A.||Minneapolis, Minnesota 55404|
|School of Dental Medicine||Buffalo, New York 14214-3008|
|St. Luke's-Roosevelt Hospital||New York, New York 10019|