High Light and Low Light Dose PDT in Glioma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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]

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: porfimer sodium
* Procedure: adjuvant therapy
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low light dose during surgery<br>Arm I: During surgery, patients receive low light dose photodynamic therapy. | Drug: porfimer sodium<br>* All patients receive porfimer sodium IV.<br>* Other names: Porfimer;Procedure: adjuvant therapy<br>* All patients receive porfimer sodium IV.<br>* Other names: Porfimer;Procedure: conventional surgery<br>* All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.<br>|
| Active Comparator: High light dose during surgery<br>Arm II: During surgery, patients receive high light dose photodynamic therapy. | Drug: porfimer sodium<br>* All patients receive porfimer sodium IV.<br>* Other names: Porfimer;Procedure: adjuvant therapy<br>* All patients receive porfimer sodium IV.<br>* Other names: Porfimer;Procedure: conventional surgery<br>* All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression and survival measured |  | at 4-6 weeks post-operatively and then every 3-4 months thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma