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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: | NCT00459381 |
RATIONALE: Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well pazopanib works in treating patients with recurrent glioblastoma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: pazopanib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of GW786034 (Pazopanib) in Patients With Recurrent Glioblastoma |
Estimated Enrollment: | 35 |
Study Start Date: | May 2007 |
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 pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 2 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme, including gliosarcoma
Must have unequivocal radiographic evidence of tumor progression by MRI, as defined by any of the following:
Treatment for no more than 2 prior relapses allowed
Relapse is defined as progression following initial therapy (i.e., radiotherapy with or without chemotherapy, if that was used as initial therapy; therefore no more than 3 prior therapies [initial therapy and therapy for 2 relapses] allowed)
PATIENT CHARACTERISTICS:
Systolic blood pressure (BP) ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg
No other conditions, including any of the following:
New York Heart Association (NYHA) class III or IV heart failure
No condition that impairs the ability to swallow and retain pazopanib hydrochloride, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior resection of recurrent or progressive tumor and recovered
More than 7 days since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)
No concurrent CYP2C9 substrates, including any of the following:
No concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)
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, 53792-6164 |
Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Responsible Party: | North American Brain Tumor Consortium ( Michael Prados ) |
Study ID Numbers: | CDR0000538083, NABTC-0602, NCI-07-C-0138 |
Study First Received: | April 9, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00459381 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult glioblastoma |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |