Malignant Glioma Clinical Trial
Official title:
Phase I/II Study of LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma
The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has no yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
- Each treatment cycle lasts 28 days (four weeks). LBH589 is taken orally three times per
week (i.e. Monday-Wednesday-Friday or Tuesday-Thursday-Sunday) every other week. Since
we are looking for the highest dose of LBH589 that can be given safely to people who
are also taking bevacizumab, not everyone who participates in this study will receive
the same amount of the drug. The dose of LBH589 given will depend on the number of
participants who have been enrolled and how well they tolerated their doses. The dose
of bevacizumab will be the same for everyone.
- On days 1 and 15 of each cycle, bevacizumab will be given as an infusion intravenously
in the clinic.
- The following tests and procedures will be performed at time intervals specified in the
protocol: physical and neurological examination; assessments of the tumor by MRI or CT
scan; routine blood tests; routine urine tests; pregnancy test for women of child
bearing potential; research blood tests and an EKG.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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