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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118222 |
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.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: porfimer sodium Procedure: adjuvant therapy Procedure: conventional surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | 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] |
Study Start Date: | March 2005 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Recurrent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Colorado | |
Rocky Mountain Neurological Alliance, P.C. | |
Englewood, Colorado, United States, 80110 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5000 | |
United States, Pennsylvania | |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 | |
Canada, Ontario | |
St. Michael's Hospital - Toronto | |
Toronto, Ontario, Canada, M5B 1W8 |
Study Chair: | Robert J. Maciunas, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000433267, CASE-4303, CWRU-00003937, CWRU-4303 |
Study First Received: | July 8, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00118222 History of Changes |
Health Authority: | United States: Federal Government |
adult mixed glioma adult anaplastic astrocytoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Adjuvants, Immunologic Central Nervous System Neoplasms Recurrence Brain Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents |
Malignant Astrocytoma Dihematoporphyrin Ether Glioma Hematoporphyrin Derivative Gliosarcoma Trioxsalen Nervous System Neoplasms |
Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Central Nervous System Neoplasms Pharmacologic Actions Neoplasms Photosensitizing Agents |
Neoplasms by Site Radiation-Sensitizing Agents Dihematoporphyrin Ether Therapeutic Uses Trioxsalen Dermatologic Agents Nervous System Neoplasms |