RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic therapy using porfimer sodium to compare how well they work in treating patients who are undergoing surgery for recurrent malignant astrocytoma.

Condition	Intervention
Mixed Gliomas adult anaplastic astrocytoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma	Drug: porfimer sodium  Procedure: adjuvant therapy  Procedure: conventional surgery  Procedure: laser therapy  Procedure: photodynamic therapy  Procedure: phototherapy  Procedure: surgery

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00118222

Colorado
      Rocky Mountain Neurological Associates, Englewood,  Colorado,  80110,  United States; Recruiting
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5000,  United States; Recruiting
Pennsylvania
      Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
Canada, Ontario
      St. Michael''''s Hospital - Toronto, Toronto,  Ontario,  M5B 1W8,  Canada; Recruiting

Study chairs or principal investigators

Robert J. Maciunas, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000433267; CASE-4303; CWRU-00003937; CWRU-4303; NCT00118222
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 8, 2005
ClinicalTrials.gov Identifier:  NCT00118222
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26