At a glance
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A Phase 2 Study of SU011248 (Sunitinib Malate) in Von Hippel-Lindau Syndrome
In Brief
A Phase 2 clinical trial evaluating SU011248 for Von Hippel-Lindau Syndrome and 2 related conditions. Terminated early, enrolled 15 participants across 1 site.
Signals
Detailed Summary
The goal of this clinical research study is to learn if sunitinib malate (SU011248) can help to control VHL. The safety of this drug will also be studied. Primary objectives: * Evaluate safety of treatment with SU011248/sunitinib malate (50 mg daily dose for 4 weeks, then 2 weeks off) for 6 months in patients with Von Hippel-Lindau Syndrome (VHL) who have a measurable lesion undergoing surveillance Secondary objectives: * Evaluate efficacy of treatment with SU011248/sunitinib malate (50 mg daily dose for 4 weeks, then 2 weeks off) for 6 months in patients with VHL who have a measurable lesion undergoing surveillance Correlative objectives: * Evaluate quality of life of SU011248/sunitinib malate therapy in VHL patients * Evaluate peripheral blood lymphocyte receptor phosphorylation in VHL patients taking SU011248/sunitinib malate (optional procedure) * Correlate results of dynamic contrast-enhanced and diffusion weighted MRI and dynamic contrast enhanced CT with response and explore findings suggestive of surrogates of early response (optional procedure)
Study Details
Timeline
Interventions
50 mg/day orally for 4 weeks, no treatment for 2 weeks (6 weeks = 1 cycle).