Status:
COMPLETED
High Light and Low Light Dose PDT in Glioma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 photody...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00118222
Start Date
March 1 2005
End Date
March 1 2006
Last Update
June 11 2010
Active Locations (1)
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1
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5000