Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
With
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of the study treatment. II. To determine the maximum tolerated dose (MTD) of daily oral alisertib when combined with fractionated stereotactic radiation treatment for recurrent high grade glioma. SECONDARY OBJECTIVES: I. To estimate 6 month progression free survival rate. II. To estimate the median time to progression. III. To estimate overall survival. IV. To estimate the impact on quality of life (QoL). OUTLINE: This is a dose-escalation study of alisertib. CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery once daily (QD) every weekday for 10 days and receive alisertib orally (PO) twice daily (BID) concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 4-6 months thereafter.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
