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Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas

Phase 2
18 Years
Open (Enrolling)
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

Thank you

Trial Information

Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas


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.


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

IV. To assess tissue for VEGF and VEGFR to correlate with response. An exploratory analysis
of HER-2 will be performed.


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.

Inclusion 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

- 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]) =<
2.5 x local laboratory upper limit of normal (ULN)

- Serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x
local laboratory upper limit of normal (ULN)

- Creatinine =< 2.0 mg/dl

- PT, INR, and PTT =< 1.5 times institutional upper limits of normal

- Total serum bilirubin =< 1.5

- Patients with a history of NF may have other stable CNS tumors, such as schwannoma,
acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size
for the preceding 6 months

- No history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ
of the cervix) unless in complete remission and off all therapy for the disease for a
minimum of 5 years

- Patients may not have a history of prior treatment with inhibitors of the VEGF
pathway (eg: VEGF trap, cediranib, vatalanib, sunitinib, sorafenib, etc.)

- No concurrent treatment on another clinical trial; supportive care trials or
non-treatment trials, e.g. QOL, are allowed

- No history of known human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS)-related illness or other active infection

- Anticoagulation with therapeutic warfarin (INR <3) and low molecular weight heparin
is allowed

- Pregnancy or breast-feeding (Patients must be surgically sterile, postmenopausal, or
agree to use effective contraception during the period of therapy; the definition of
effective contraception will be based on the judgment of the principal investigator
or a designated associate)

- Male patients must be surgically sterile or agree to use effective contraception;
women of childbearing potential must have a negative B-HCG pregnancy test documented
within 14 days prior to registration

- Patient must be able to comply with the study and follow-up procedures

- Life expectancy greater than 12 weeks

- Adequately controlled hypertension (defined as systolic blood pressure =< 150 mmHg
and/or diastolic blood pressure =< 100 mmHg)

- No history of hypertensive crisis or hypertensive encephalopathy

- Patients must not have New York Heart Association (NYHA) Grade II or greater
congestive heart failure

- No history of myocardial infarction or unstable angina within 12 months prior to Day
1 of treatment

- No history of stroke or transient ischemic attack

- Patients must not have significant vascular disease (e.g., aortic aneurysm, requiring
surgical repair or recent peripheral arterial thrombosis) within 6 months prior to
Day 1 of treatment

- No history of hemoptysis (>= 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

- Urine protein:creatinine (UPC) ratio =< 1.0 at screening OR urine dipstick for
proteinuria < 2 (patients discovered to have >= 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

At 6 months

Safety Issue:


Principal Investigator

Priya Kumthekar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

NU 09C2



Start Date:

July 2010

Completion Date:

July 2015

Related Keywords:

  • 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
  • Brain Neoplasms
  • Ependymoma
  • Hemangiopericytoma
  • Meningioma
  • Neurilemmoma
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Neurofibromatosis 2
  • Neuroma, Acoustic



Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Washington Seattle, Washington  98195
University of Virginia Charlottesville, Virginia  22908
Northwestern University Chicago, Illinois  60611
Columbia University Medical Center New York, New York  10032