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Phase 2 N=50 Treatment

Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas

Acoustic Schwannoma · Adult Anaplastic Meningioma · Adult Ependymoma · Adult Grade I Meningioma · Adult Grade II Meningioma

Enrolled (actual)
50
Serious AEs
44.0%
Results posted
Jan 2021
Primary outcome: Primary: Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months — 93; 85; 51; 73 percentage of patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
bevacizumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Mar 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months
93; 85; 51; 73
SECONDARY
Number of Patients With Each Response
0; 2; 43; 4; 1
SECONDARY
Safety Profile of Bevacizumab
10; 2; 2; 1; 1; 1
SECONDARY
Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response
1; 30; 1; 10; 0; 0
SECONDARY
Number of Patients Alive at 1 Year, 2 Years and 3 Years Post Treatment Initiation (Overall Survival) for Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab
43; 31; 16

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.

Eligibility Criteria

Criteria

  • Histologically proven recurrent or progressive intracranial meningioma; this includes benign, atypical, or malignant meningioma who may or may not have neurofibromatosis type 1 or 2; pathology can be from initial surgery; OR histologically proven intracranial hemangiopericytoma, hemangioblastoma (with or without metastatic disease), acoustic neuroma, or intracranial schwannoma
  • Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated); the scan must be performed within 14 days of registration
  • Steroid dosing- must be on stable dose for at least 5 days prior to baseline imaging (Steroids are not required at the time of baseline imaging)
  • Recent resection for recurrent tumor - patients will be eligible as long as they are greater than four weeks from surgery, have recovered from the effects of surgery, and have residual disease that can be evaluated; to best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively; if the 96 hour scan is more than 14 days before registration, it should be repeated
  • Prior radiation therapy - patients may have been treated with standard external beam radiation or radiosurgery in any combination; an interval of >= 8 weeks (56 days) must have elapsed from the completion of radiation therapy to study entry and there must be subsequent evidence of tumor progression
  • Patients with prior stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR spectroscopy or surgical documentation of disease
  • Prior therapy: there is no limitation on the number of prior surgeries, radiation therapy, radiosurgery treatments, or chemotherapy agents
  • Prior surgery: must be > 4 weeks from surgery
  • Prior radiation: must be 8 weeks from end of treatment
  • Prior chemotherapy: must be at least 4 weeks from cytotoxic therapy and 2 weeks from biologic therapies
  • All patients must sign an informed consent indicating that they are aware of the investigational nature of the study
  • Patients must sign an authorization for the release of their protected health information
  • Karnofsky performance status >= 60%
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 8gm/dl
  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) = = 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of treatment
  • No evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • No history of major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
  • No history of minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of treatment
  • No history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of treatment
  • Patients must not have serious non-healing wound, active ulcer, or unhealed bone fracture
  • Urine protein: creatinine (UPC) ratio = = 2 proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
  • No known hypersensitivity to any component of bevacizumab
  • Patients may not have a prior history of bowel perforation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01125046). 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.

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