Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma

Completed · Phase 2

Conditions studied: Glioblastoma, Gliosarcoma

In brief

Primary Objective To estimate 6-month progression free survival probability of patients with recurrent glioblastoma multiforme treated with bortezomib plus Avastin. This efficacy assessment will be made separately among patients on enzyme-inducing anti-epileptic drugs and non enzyme-inducing anti-epileptic drugs. Secondary Objectives To evaluate safety \& tolerability of bortezomib plus Avastin among patients with recurrent malignant glioma. To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with bortezomib plus Avastin

Key facts

Study ID

NCT00611325

Run by

Duke University

People needed

56

Starts

2008-05-01

Expected to finish

2013-10-01

Last updated by the study team

2014-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients have histologically confirmed diagnosis of recurrent/progressive WHO grade IV malignant glioma (MG)
• Age >18 yrs
• No prior treatment with bortezomib, \& no Avastin in last 3 months, not allowed to have progressed to Avastin regimen. No history of > or equal to grade 2 CNS hemorrhage or grade 3 or higher toxicities while on Avastin
• At least 6 weeks from surgical resection, 4 weeks from end of radiotherapy \& enrollment in this study
• Karnofsky Performance Status (KPS) > or equal to 70%
• Hemoglobin (Hgb) > or = to 9 g/deciliter (dL), absolute neutrophil count (ANC) > or = to 1,500 cells/microliter, platelets > or = to 125,000 cells/microliter;
• Serum creatinine <1.5 mg/dL, serum glutamic oxalocetic transaminase (SGOT) \& bilirubin <1.5 x upper limit of normal
• Signed informed consent approved by IRB;
• If sexually active, patients must agree to take contraceptive measures for duration of treatments
• May have had up to 3 biological therapies (such as tyrosine kinase inhibitors, topoisomerase I or II inhibitors, or rapamycin)

You may not qualify if…

• Gr 2 or greater peripheral neuropathy at time of study enrollment
• No prior taxanes, as it predisposes to sensory neuropathy
• Co-medication that may interfere with study results, e.g. immuno-suppressive agents other than corticosteroids
• Greater than 3 prior recurrences
• Evidence of CNS hemorrhage on baseline MRI on CT scan (except for grade 1 hemorrhage that has been stable for at least 3 months)
• History of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months
• Requires therapeutic anti-coagulation
• At least 4 weeks from Day 0 of prior monthly chemotherapy (at least 6 weeks if a nitrosourea). At least 1 week from last dose of daily chemotherapy (such as metronomic temozolomide, cytoxan) or targeted therapies administered daily (such as gleevec, tarceva)
• Pregnancy or breast feeding
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics \& psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state
• Patients with another primary malignancy that has required treatment within past year.
• Avastin-Specific Concerns:
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• Systolic blood pressure (BP) > 150 mmHg or diastolic BP > 100 mmHg
• Unstable angina
• New York Heart Association Gr II or > congestive heart failure
• History of myocardial infarction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis, coagulopathy as documented by an elevated prothrombin time (PT), partial thromboplastin time (PTT)/bleeding time
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during course of study
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
• Urine protein: creatinine ratio > or = to 1.0 at screening
• History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 0
• Serious, non-healing wound, ulcer, or bone fracture

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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