Photodynamic Therapy Using Porfimer Sodium in Treating Patients Who Are Undergoing Surgery for Recurrent Malignant Astrocytoma

Condition(s) targeted: Brain and Central Nervous System Tumors

Intervention: porfimer sodium (Drug); adjuvant therapy (Procedure); conventional surgery (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Case Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Robert J. Maciunas, MD, Study Chair, Affiliation: Case Comprehensive Cancer Center

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.

Official title: A Randomized Prospective Two Arm Clinical Trial of High Light Dose And Low Light Dose PDT in the Treatment of Recurrent Malignant Supratentorial Gliomas Using Porfimer Sodium [Photofrin]

Study design: Treatment, Randomized

Primary outcome:

Survival measured at 4-6 weeks post-operatively and then every 3-4 months thereafter

Time to progression measured at 4-6 weeks post-operatively and then every 3-4 months

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Rocky Mountain Neurological Alliance, P.C., Englewood, Colorado 80110, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5000, United States

St. Michael's Hospital - Toronto, Toronto, Ontario M5B 1W8, Canada

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2005
Last updated: May 23, 2008