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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00016991 |
Purpose
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: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme |
| Study Start Date: | June 2001 |
| Study Completion Date: | April 2005 |
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.
Eligibility| 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:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Henry S. Friedman, MD | Duke University |
More Information
| Responsible Party: | Henry Friedman, MD, Duke UMC |
| ClinicalTrials.gov Identifier: | NCT00016991 History of Changes |
| Other Study ID Numbers: | CDR0000068639, DUMC-2421-03-2R2, DUMC-2421-01-2, NCI-1253 |
| Study First Received: | June 6, 2001 |
| Last Updated: | October 12, 2009 |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |