Photodynamic Therapy in Treating Patients With Recurrent, Refractory, or Second Primary Head and Neck Cancer That Cannot Be Treated With Surgery or Radiation Therapy
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00003856
- Lead Sponsor
- Quintiles, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
St. Luke's-Roosevelt Hospital
🇺🇸New York, New York, United States
School of Dental Medicine
🇺🇸Buffalo, New York, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Ear, Nose, and Throat Specialty Care of Minnesota, P.A.
🇺🇸Minneapolis, Minnesota, United States
Division of Head and Neck Surgery
🇺🇸Evanston, Illinois, United States
Norton Healthcare Pavilion
🇺🇸Louisville, Kentucky, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States