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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00430079 |
RATIONALE: Diagnostic procedures using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment.
PURPOSE: This clinical trial is using EF5 to measure the oxygen level in tumor cells of patients undergoing surgery or surgery biopsy for newly diagnosed supratentorial malignant glioma.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Drug: EF5 Procedure: biopsy Procedure: conventional surgery Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Assessment of Hypoxia in Malignant Gliomas Using EF5 |
Estimated Enrollment: | 48 |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: Patients receive etanidazole derivative EF5 IV over 1-2½ hours once within 1-2 days before surgical resection or biopsy. Tumor tissue, normal tissue, and/or tumor-infiltrated lymph node samples are collected during surgery and stained for biological markers. Fluorescent immunohistochemistry techniques are used to determine the presence, distribution, and levels of EF5 binding.
Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1½-2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | Kevin Judy, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000068962, UPCC-1301, UPCC-IRB-702859, NCI-4950 |
Study First Received: | January 30, 2007 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00430079 |
Health Authority: | United States: Food and Drug Administration |
adult glioblastoma adult anaplastic astrocytoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult mixed glioma adult pilocytic astrocytoma |
adult subependymoma adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma adult ependymoma adult diffuse astrocytoma adult pineal gland astrocytoma |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Ependymoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |