Phase 2 Study of Bevacizumab in Children and Young Adults With NF 2 and Progressive Vestibular Schwannomas

Completed · Phase 2

Conditions studied: Neurofibromatosis Type 2, Progressive Vestibular Schwannomas

In brief

To determine the hearing response rate at 24 weeks after treatment with bevacizumab for symptomatic vestibular schwannomas (VS) in children and young adults with Neurofibromatosis Type 2 (NF 2).

Key facts

Study ID

NCT01767792

Run by

University of Alabama at Birmingham

People needed

22

Starts

2013-05-15

Expected to finish

2020-02-01

Last updated by the study team

2021-02-12

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior radiation treatment to the target vestibular schwannoma is allowed if provided 3 years prior to participation in the clinical trial. Prior radiation treatment to non-target tumors is allowed.
• Participants may not be receiving any other study agents.
• Patients with nervous system tumors associated with NF2 (e.g., schwannomas, meningiomas, ependymomas, or gliomas) will not be excluded from this clinical trial unless (in the opinion of the investigator) these tumors are growing and are likely to require treatment during the clinical trial.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab.
• Patients with known hypersensitivity of Chinese hamster ovary cell products, other recombinant human antibodies, or compounds of similar chemical or biologic composition to bevacizumab.
• Inability to tolerate periodic MRI scans or gadolinium contrast.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of arterial/myocardial disease.
• Clinically significant cardiovascular disease, such as:
• Inadequately controlled hypertension (HTN) (for adults: Systolic Blood Pressure (SBP) > 160 mmHg and/or Diastolic Blood Pressure (DBP) > 90 mmHg despite antihypertensive medication; for children: please refer to Appendix D for age-appropriate values indicating ≥ Grade 2)
• History of cerebrovascular accident (CVA) within 12 months
• Myocardial infarction or unstable angina within 12 months
• New York heart association grade II or greater congestive heart failure
• Serious and inadequately controlled cardiac arrhythmia
• Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)
• Clinically significant peripheral vascular disease
• Pregnant women are excluded from this study because bevacizumab is an anti-angiogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with bevacizumab, breastfeeding should be discontinued if the mother is treated with bevacizumab. These potential risks may also apply to other agents used in this study.
• HIV-positive patients or cancer survivors are eligible for this study if they fulfill all other eligibility criteria.
• Concurrent use of anti-coagulant drugs (not including prophylactic doses), history of coagulopathy, or evidence of bleeding diathesis or coagulopathy.
• Imaging (CT or MRI) evidence of hemorrhage deemed significant by the treating physician (> grade 1). Subjects with history of central nervous system (CNS) hemorrhage are not eligible.
• Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be <1000 mg for patient enrollment.
• Serious or non-healing wound, ulcer or bone fracture.
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1.
• Invasive procedures defined as follows:

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's HealthCare of Atlanta — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana Unversity — Indianapolis, Indiana, United States
• National Cancer Institute (NCI) — Bethesda, Maryland, United States
• Children' Hospital Boston and Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University - St. Louis — St Louis, Missouri, United States
• New York University Medical Center — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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