Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
- 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)
Recurrent tumor patients (Study 2)
- Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection
- 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
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)
Allocation: Randomized, Primary Purpose: Treatment
Fred W. Hetzel, PhD, JD
Colorado Health Foundation
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224|
|Rocky Mountain Neurological Associates||Englewood, Colorado 80110|