NCT00118222

High Light and Low Light Dose PDT in Glioma

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]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	porfimer sodium	All patients receive porfimer sodium IV.
PROCEDURE	adjuvant therapy	All patients receive porfimer sodium IV.
PROCEDURE	conventional surgery	All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-07-11
• Last updated: 2010-06-11

Locations

1 site across 1 country: United States