Clinical and Molecular-Metabolic Phase II Trial of Perifosine for Recurrent/Progressive Malignant Gliomas
This is a phase II study of the small molecule inhibitor perifosine (NSC 639966, D21266,
KRX-0401) in the treatment of patients with recurrent glioblastoma multiforme (GBM) and
other recurrent malignant gliomas. The goal of the phase II study is to determine efficacy
as measured by the progressionfree survival rate after 6 months of treatment. Secondary
goals include determination of molecular and metabolic effects of perifosine by tissue
analysis and PET imaging.
In addition, when cytoreductive surgery is recommended as part of the standard of care at
study entry, patients will be considered for a "surgical arm." In this case, patients will
receive perifosine for 5-10 days before surgery during which tumor will be aliquoted both
for diagnostic purposes and for molecular effects of the drug in vivo and for analysis of
drug penetration into tumor tissue.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the efficacy of perifosine in patients with recurrent/progressive GBMs not taking EIAEDs as measured by 6mPFS.
Thomas Kaley, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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