Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1 participants
INTERVENTIONAL
2005-03-31
2006-03-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Low light dose during surgery
Arm I: During surgery, patients receive low light dose photodynamic therapy.
porfimer sodium
All patients receive porfimer sodium IV.
adjuvant therapy
All patients receive porfimer sodium IV.
conventional surgery
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
High light dose during surgery
Arm II: During surgery, patients receive high light dose photodynamic therapy.
porfimer sodium
All patients receive porfimer sodium IV.
adjuvant therapy
All patients receive porfimer sodium IV.
conventional surgery
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
Interventions
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porfimer sodium
All patients receive porfimer sodium IV.
adjuvant therapy
All patients receive porfimer sodium IV.
conventional surgery
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigators
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Robert J. Maciunas, MD
Role: STUDY_CHAIR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE-4303
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU-00003937
Identifier Type: -
Identifier Source: secondary_id
CWRU-4303
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU4303
Identifier Type: -
Identifier Source: org_study_id
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