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]
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Time to progression and survival measured
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
Intervention: porfimer sodium (Drug)
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
Intervention: adjuvant therapy (Procedure)
Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
Intervention: conventional surgery (Procedure)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
Intervention: porfimer sodium (Drug)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
Intervention: adjuvant therapy (Procedure)
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
Intervention: conventional surgery (Procedure)
Outcomes
Primary Outcomes
Time to progression and survival measured
Time Frame: at 4-6 weeks post-operatively and then every 3-4 months thereafter
Secondary Outcomes
No secondary outcomes reported