High Light and Low Light Dose PDT in Glioma

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant supratentorial astrocytoma, glioblastoma, or mixed oligo-astrocytoma

• Grade 3 or 4 tumor, defined as presence of ≥ 2 of the following features:

• Nuclear atypia
• Mitosis
• Endothelial proliferation
• Necrosis
• Recurrent disease

• Failed prior surgery and radiotherapy
• Tumor suitable for radical resection by imaging studies

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing to avoid direct sun-light exposure for 6 weeks after photodynamic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics