OBJECTIVES:
* Determine whether the addition of photodynamic therapy to standard brain tumor care (surgical resection, postoperative radiotherapy, and chemotherapy) will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas.
* Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas.
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
* Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
* Arm I: Patients receive porfimer sodium (Photofrin) IV one day prior to surgery. Craniotomy and tumor resection are performed. Upon completion of resection, patients undergo intracavitary photoillumination with a high light dose.
* Arm II: Craniotomy and tumor resection are performed. Postoperatively, all patients receive external beam radiotherapy 5 days per week for 5-6 weeks. After completing radiotherapy, patients receive nitrosourea (carmustine or lomustine) chemotherapy.
Recurrent tumor patients (Study 2)
* Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed.
* Arm I: Patients receive high dose light therapy during surgery.
* Arm II: Patients receive low dose light therapy during surgery. Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure.
PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
