Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01125046
• Date of registration: 07/05/2010
• Prospective Registration: Yes
• Primary sponsor: Northwestern University
• Public title: Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas
• Scientific title: Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas
• Date of first enrolment: July 2010
• Target sample size: 50
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT01125046
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Priya Kumthekar, MD
• Affiliation: Northwestern University

Key inclusion & exclusion 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]) =<
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
fracture

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent Adult Brain Tumor

Adult Ependymoma

Adult Grade I Meningioma

Acoustic Schwannoma

Adult Anaplastic Meningioma

Adult Grade II Meningioma

Neurofibromatosis Type 1

Adult Papillary Meningioma

Neurofibromatosis Type 2

Adult Meningeal Hemangiopericytoma

Intervention(s)

Biological: bevacizumab

Primary Outcome(s)

Progression free survival [Time Frame: At 6 months]

Secondary Outcome(s)

Levels of VEGF and VEGFR expression in tumor tissue as compared to response rate [Time Frame: At baseline and every 8 weeks until disease progression or death]

Response rate and overall-survival [Time Frame: During week 8, every 8 weeks thereafter while on treatment and intermittently during followup]

Safety profile of bevacizumab [Time Frame: Every 2 weeks while on treatment up to 28 days after the last dose]

Secondary ID(s)

NU 09C2

NCI-2010-00843

STU00024715

Source(s) of Monetary Support

Please refer to primary and secondary sponsors