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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016991 |
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.
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, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Henry S. Friedman, MD | Duke University |
Study ID Numbers: | CDR0000068639, DUMC-2421-03-2R2, DUMC-2421-01-2, NCI-1253 |
Study First Received: | June 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016991 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Glioblastoma multiforme |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Gefitinib Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |