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)

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma

  • Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification
• Suitable for radical resection on the basis of imaging studies
• Patients with recurrent disease must have failed surgery and radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100% for newly diagnosed tumor
• Karnofsky 70-100% for recurrent tumor

Life expectancy:

• At least 3 months

Hematopoietic:

• Recurrent tumor:

  • WBC at least 2,000/mm^3
  • Platelet count at least 80,000/mm^3

Hepatic:

• Recurrent tumor:

  • PT/PTT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin and LFTs less than 2 times ULN
  • Alkaline phosphatase no greater than 3 times ULN
  • GGT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2 mg/dL

Other:

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior cranial radiotherapy for newly diagnosed tumor

Surgery:

• See Disease Characteristics