Status:
COMPLETED
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
Lead Sponsor:
Duke University
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Genentech, Inc.
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ma...
Detailed Description
This is an open-label, 2-arm Phase II study assessing safety \& efficacy of bortezomib in combination with Avastin for patients with recurrent glioblastoma multiforme (gbm). 56 total patients with rec...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- Known hypersensitivity to any component of Avastin
- Inability to comply with study and/or follow-up procedures
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00611325
Start Date
May 1 2008
End Date
October 1 2013
Last Update
March 12 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710