This phase 0 trial studies ixazomib citrate in treating patients with glioblastoma that has spread or returned after period of improvement who are planning to undergo surgery. When given by mouth, ixazomib may be able to reach tumor cells in the brain. Studying samples of tissue, blood, and plasma in the laboratory from patients receiving ixazomib may help doctors learn more about the effects of ixazomib on the cells. It may also help doctors understand how well patients will respond to treatment.
PRIMARY OBJECTIVES: I. Measurement of tissue concentration of ixazomib (ixazomib citrate) in a glioblastoma after preoperative administration. II. Measurement of blood and plasma concentration of ixazomib during surgical sampling after preoperative administration. SECONDARY OBJECTIVE: I. Assessment of the safety of ixazomib after single dose administration in glioblastoma patients undergoing surgery for tissue concentration assessment. OUTLINE: Patients receive ixazomib orally (PO) 3 hours before surgery. After completion of study, patients are followed up for 30 days and then periodically thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
3
Given PO
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Concentration of Ixazomib in Tumor Tissue
The relationship between patient's demographic, tumor and drug concentration results will be assessed with Pearson's correlation coefficient and tested with Wald's test. In addition, the mean and standard error of the concentrations will be estimated using a random-effects model to account for the within-patient correlation of the tumor biopsy samples. Given the limited number of observations, a relatively simple covariance matrix (e.g. compound symmetry) will be assumed.
Time frame: At time of surgery, approximately 3 hours
Number of Patients With Safety and Tolerability of Ixazomib
Safety was assessed with routine postoperative laboratory, vital sign, neurologic exam, and imaging studies through the day of surgery to staple or suture removal. This data was collected and any adverse events graded and their relationship to ixazomib administration determined.
Time frame: At the time of surgery, approximately 3 hours
Number of Participants With Treatment-Emergent Adverse Events
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) was used to stratify any adverse patient response to ixazomib. There were no clinically relevant adverse events as a result of ixazomib administration.
Time frame: Up to 30 days
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