Trials / Completed
CompletedNCT01125046
Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas
Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progression meningiomas.
Detailed description
PRIMARY OBJECTIVES: I. To determine the efficacy of bevacizumab in patients with recurrent or progressive benign and atypical/malignant meningiomas, despite prior therapy, as measured by six-month progression-free survival. SECONDARY OBJECTIVES: I. To describe the response rate and overall-survival in this patient population. II. To evaluate the safety profile of bevacizumab in patients with recurrent meningiomas. III. To perform an exploratory study in patients with hemangioblastoma and hemangiopericytoma. IV. To assess tissue for VEGF and VEGFR to correlate with response. An exploratory analysis of HER-2 will be performed. OUTLINE: Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months. Patients may then receive bevacizumab IV every 3 weeks for up to 12 months. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years.
Conditions
- Acoustic Schwannoma
- Adult Anaplastic Meningioma
- Adult Ependymoma
- Adult Grade I Meningioma
- Adult Grade II Meningioma
- Adult Meningeal Hemangiopericytoma
- Adult Papillary Meningioma
- Neurofibromatosis Type 1
- Neurofibromatosis Type 2
- Recurrent Adult Brain Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | bevacizumab | Given IV |
Timeline
- Start date
- 2010-06-17
- Primary completion
- 2014-03-10
- Completion
- 2018-12-31
- First posted
- 2010-05-18
- Last updated
- 2021-01-22
- Results posted
- 2021-01-22
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01125046. Inclusion in this directory is not an endorsement.