Phase 2
N=56
Phase II Avastin + Bortezomib for Patients With Recurrent Malignant Glioma
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00611325 ↗Enrolled (actual)
56
Serious AEs
28.6%
Results posted
Feb 2014
Primary outcome: Primary: 6-month Progression-free Survival (PFS) — 25; 28.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Avastin (Drug); Bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Progression-free Survival (PFS) |
25; 28.6 | — |
| SECONDARY Median Progression Free Survival (PFS) |
2; 2.5 | — |
| SECONDARY Median Overall Survival (OS) |
8; 6 | — |
| SECONDARY Radiographic Response Rate |
7.1; 39.3 | — |
| SECONDARY Number of Patients With Grade 3 or Greater, Treatment-related, Non-hematologic Toxicities |
27; 24 | — |
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 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
Eligibility Criteria
Inclusion Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00611325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.