Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas

NCT ID: NCT01125046

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-17
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

Given IV

Interventions

bevacizumab

Given IV

Intervention Type: BIOLOGICAL

Other Intervention Names

anti-VEGF humanized monoclonal antibody; anti-VEGF monoclonal antibody; anti-VEGF rhuMAb; Avastin; recombinant humanized anti-VEGF monoclonal antibody; rhuMAb VEGF

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Priya Kumthekar, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

University of Virginia

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2010-00843

Identifier Type: -

Identifier Source: secondary_id

STU00024715

Identifier Type: OTHER

Identifier Source: secondary_id

NU 09C2

Identifier Type: -

Identifier Source: org_study_id