Trial Information

Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors

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)