Expired Study
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Baltimore, Maryland 21231


Purpose:

Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth


Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma. II. Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients. III. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs). Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated with bortezomib at the MTD. Patients are followed every 2 months.


Criteria:

Inclusion Criteria: - Histologically confirmed progressive or recurrent malignant glioma - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Glioblastoma multiforme - Prior low-grade gliomas that have progressed to high-grade after therapy allowed - Measurable disease by MRI or CT scan - Performance status - Karnofsky 60-100% - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - Transaminases no greater than 4 times upper limit of normal - Creatinine no greater than 1.7 mg/dL - Mini mental score at least 15 - No concurrent serious infection or other medical illness that would preclude study participation - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No more than 1 prior chemotherapy regimen - At least 3 months since prior radiotherapy and recovered - No other concurrent investigational agents


NCT ID:

NCT00006773


Primary Contact:

Principal Investigator
Jeffrey Olson
New Approaches to Brain Tumor Therapy Consortium


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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