At a glance
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A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
In Brief
A Phase 2 clinical trial evaluating Sunitinib Malate for Anaplastic Astrocytoma and Glioblastoma. Completed, enrolled 30 participants across 1 site.
Detailed Summary
We are asked patients to take part in this study because they had recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). The purposes of this study are: * To see if Sutent has any change on the patient and their cancer. * To see if Sutent will slow or stop the growth of their tumor. * To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer.
Study Details
Timeline
Interventions
Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.