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Sponsors and Collaborators: |
North American Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103129 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving lapatinib before surgery may shrink the tumor so it can be removed. Giving it after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients who are undergoing surgery for recurrent progressive glioblastoma multiforme or gliosarcoma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: lapatinib ditosylate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Biomarker and Phase II Study of GW572016 in Recurrent Malignant Glioma |
Estimated Enrollment: | 44 |
Study Start Date: | February 2005 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral lapatinib twice daily for 7-10 days. Patients then undergo surgical resection. Within 28 days after surgery, patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-12 months.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma
Evidence of tumor progression by MRI or CT scan
Patients who received prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis by 1 of the following:
Patients may have been treated for no more than 2 prior relapses*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)
At least 14 days since prior and no concurrent inducers of CYP3A4, including any of the following:
At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:
No use of gastric pH modifiers within 1 hour before or after study drug administration, including any of the following:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan - Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
UPMC Cancer Centers | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
M. D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | H. I. Robins, MD, PhD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000409728, NABTC-0401, NCI-05-C-0134 |
Study First Received: | February 7, 2005 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00103129 |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor |
Glioblastoma Astrocytoma Lapatinib Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Neoplasms, Neuroepithelial Protein Kinase Inhibitors Pharmacologic Actions |