A Randomized Prospective Two Arm Clinical Trial of High Light Dose And Low Light Dose PDT in the Treatment of Recurrent Malignant Supratentorial Gliomas Using Porfimer Sodium [Photofrin]
- Compare survival of patients undergoing surgical resection for recurrent high-grade
malignant supratentorial astrocytoma treated with intraoperative high vs low light dose
photodynamic therapy using porfimer sodium.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 2 treatment arms.
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and
- Arm I: During surgery, patients receive low light dose photodynamic therapy.
- Arm II: During surgery, patients receive high light dose photodynamic therapy. After
completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months
and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression and survival measured
at 4-6 weeks post-operatively and then every 3-4 months thereafter
Robert J. Maciunas, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|