Brain and Central Nervous System Tumors Clinical Trial
Official title:
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]
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active
when it is exposed to a certain kind of light. When the drug is active, tumor cells are
killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized clinical trial is studying two different light doses of
photodynamic therapy using porfimer sodium to compare how well they work in treating
patients who are undergoing surgery for recurrent malignant astrocytoma.
OBJECTIVES:
- 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
tumor resection.
- 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
years.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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