A Phase II Trial Evaluating the Effects of Bortezomib in Patients With Recurrent Malignant Gliomas Treated Prior to Surgery and Then Bortezomib and Temozolomide Post-operatively
Patients receive bortezomib IV on days 1, 4, and 8. Patients then undergo surgical resection
of the tumor on day 8 or 9.
Beginning approximately 14 days after surgery, patients receive oral temozolomide on days
1-7 and 14-21 and bortezomib IV on days 7 and 21. Treatment repeats every 28 days for up to
2 years in the absence of disease progression or unacceptable toxicity.
Tumor tissue and blood samples are collected periodically for biomarker analysis, gene
methylation studies, and pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlative Profiles with therapy response and patient survival.
To determine the effects of Bortezomib on the endogenous modulators of NF-Kappa B pathways, especially NFKBIA, via novel assay technology, and correlate profiles with therapy response and patient survival.
Samples drawn pre-surgery, Bortezomib treatment day 1, Drawn prior to surgery, Day prior to treatment post surgery, and Day of MRI every cycle POST-surgery, tissue evaluated at study completion
Jeffrey Raizer, MD
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|