Brain and Central Nervous System Tumors Clinical Trial
Official title:
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
Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving bortezomib before surgery may make the tumor smaller and reduce the amount
of normal tissue that needs to be removed. Giving bortezomib together with temozolomide
after surgery may kill any tumor cells that remain after surgery.
This phase II trial is studying how well giving bortezomib before surgery followed by giving
bortezomib together with temozolomide after surgery works in treating patients with
recurrent malignant glioma.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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