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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00713388 |
RATIONALE: Sunitinib 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 how well sunitinib works in treating patients with recurrent malignant glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Sunitinib in the Treatment of Recurrent Malignant Glioma |
Estimated Enrollment: | 128 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to prior treatment with bevacizumab (yes vs no) and disease histology (glioblastoma multiforme or gliosarcoma vs anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic mixed oligoastrocytoma).
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Health-related quality of life is assessed at baseline, every 4 weeks during treatment, and within 2 weeks after completion of treatment.
After completion of study treatment, patients are followed within 2 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intracranial malignant glioma, including any of the following subtypes:
Disease progression after prior treatment with radiotherapy and temozolomide, as evidenced by contrast-enhanced perfusion MRI or CT scan within the past 14 days
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Prior recent resection of recurrent or progressive tumor allowed
More than 6 weeks since prior bevacizumab
More than 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), including any of the following:
More than 2 weeks since prior and no concurrent potent CYP3A4 inhibitors, including any of the following:
More than 2 weeks since prior and no concurrent potent CYP3A4 inducers, including any of the following:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Teri N. Kreisl, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000599821, NCI-08-C-0168, NCI-P07336 |
Study First Received: | July 10, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00713388 |
Health Authority: | Unspecified |
adult anaplastic oligodendroglioma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
adult anaplastic astrocytoma recurrent adult brain tumor adult mixed glioma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors Sunitinib |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial |