Eligibility: b6c6149ed38bedaf916066375b932319 [RDF]
| Label | b6c6149ed38bedaf916066375b932319 |
|---|---|
| Slug | b6c6149ed38bedaf916066375b932319 |
| Criteria | Inclusion Criteria: - Must be >- 18 years old, with a life expectancy > 8 weeks - Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma - Must submit an unstained paraffin block or slides from surgical procedure - Patients without prior treatment and with prior diagnosis of lower-grade gliomas that have been upgraded to GBM after repeated resection allowed - At least 21 days since cranial MRI or contrast CT scan OR ≥ 96 hours since cranial MRI or contrast CT scan for patients who underwent surgical resection - Measurable or assessable disease - Voluntary written informed consent obtained before performance of any study related procedure not part of normal medical care. - Karnofsky performance status > 60% - WBC ≥ 3,000/mm^3 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL (transfusion allowed) - Bilirubin < 2.5 times upper limit of normal (ULN) - SGOT < 2.5 times ULN - Creatinine < 1.5 mg/dL - Creatinine clearance ≥ 20 mL/minute - Serum sodium > 130 mmol/L - Negative pregnancy test - Fertile patients must use effective contraception - Patients on EIAED must be transitioned to non-EAIED for ≥ 2 weeks - Concurrent full-dose warfarin or its equivalent (e.g., unfractionated and/or low molecular weight heparin) allowed Exclusion Criteria: - peripheral neuropathy ≥ grade 2 - Myocardial infarction within the past 6 months - NYHA class III or IV heart failure - Uncontrolled angina - Severe uncontrolled ventricular arrhythmias - Electrocardiographic evidence of acute ischemia or active conduction system abnormalities - hypersensitivity to bortezomib, boron, or mannitol - serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following: - Ongoing or active infection requiring IV antibiotics - Psychiatric illness and/or social situations that would limit compliance with study requirements - Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus) - history of stroke within the past 6 months - other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy - significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy - disease that will obscure toxicity or dangerously alter drug metabolism - viral hepatitis (HBV surface antigen positive) or active hepatitis C infection - Prior or concurrent corticosteroids, automated external defibrillator, analgesics, and other drugs to treat symptoms or prevent complications allowed - concurrent investigational drugs that must be stopped at least 4 months prior to therapy. - prior radiotherapy to the brain - prior cytotoxic or noncytotoxic drug therapy or experimental drug therapy (including chemotherapy, hormonal therapy, or immunotherapy) directed against the brain tumor - prior polifeprosan 20 with carmustine implant (Gliadel wafer) - concurrent stereotactic radiosurgery or brachytherapy - concurrent sargramostim - concurrent inducers of CYP450 3A4 (e.g., enzyme-inducing anti-epileptic drugs [EIAED]) |
| Maximum age | N/A |
| Healthy volunteers | No |
| Study pop | |
| Minimum age | 18 Years |
| Gender | Both |
| Sampling method | |
| Provenances | http://clinicaltrials.gov/show/NCT00998010?displayxml=true |
| Similars | None |
| Interlinks | None |
