Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma

Paused · Phase 1

Conditions studied: Vestibular Schwannoma

In brief

A recent study by Plotkin et al. showed that bevacizumab (Avastin) treatment was followed by clinically meaningful hearing improvement, tumor-volume reduction, or both in some, but not all, patients with Vestibular Schwannoma (VS) who were at risk for complete hearing loss or brain-stem compression from growing VS. Because of the promising results in preliminary studies of Bevacizumab and because of significant experience with the safety of the dosages proposed in this study, this study will offer a safe treatment for patients with VS. Therefore, this phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS.

Key facts

Study ID

NCT01083966

Run by

Northwell Health

People needed

30

Starts

2011-08-01

Expected to finish

2027-01-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients of >= 18 years of age.
• Patients with a documented diagnosis of unilateral or bilateral VS based on MRI and who have evidence of progressive vestibular schwannomas, and are considered poor candidates for surgery and radiation therapy or declined these treatments.
• Patients must have a Karnofsky performance status >=60% (or the equivalent ECOG level of 0-2) (see Appendix A; Performance Status Evaluation) and an expected survival of >= three months.
• No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for two weeks prior to treatment under this research protocol.
• Patients must have adequate hematologic reserve with WBC>=3000/mm3, absolute neutrophils >=1500/mm3 and platelets >=100,000/ mm3. Patients who are on Coumadin must have a platelet count of >=150,000/ mm3.
• Pre-enrollment chemistry parameters must show: bilirubin< 1.5X the institutional upper limit of normal (IUNL); AST or ALT< 2.5X IUNL and creatinine < 1.5X IUNL.
• Pre-enrollment coagulation parameters (PT and PTT) must be <1.5X the IUNL.
• Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.

You may not qualify if…

• Previous treatment with Avastin®.
• Women who are pregnant or lactating.
• Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
• Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring including MRI with gadolinium.
• Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during study treatment.
• Current or recent (within 10 days of Avastin) use of aspirin (> 325 mg/day), full dose (i.e., therapeutic dose) of oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed (e.g., warfarin (1 mg qd) for catheter prophylaxis, and prophylactic low molecular-weight heparin (i.e., enoxaparin [(40mg QD0]).
• History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding.
• Inadequately controlled hypertension (blood pressure: systolic > 150 mmHg and/or diastolic > 100 mmHg).
• Patients with baseline urine dipstick for proteinuria > 2+ must undergo a 24-hours urine collection and must demonstrate ≤ 1 g of protein in 24 hours.
• Clinically significant (i.e., active) cardiovascular disease (e.g., cerebrovascular accident or myocardial infarction within 6 months prior to randomization),unstable angina, congestive heart failure (NYHA Class ≥ II), or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with administration of study treatment.
• Serious non-healing sound, active peptic ulcer, or untreated bone fracture.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
• Known hypersensitivity to Avastin or any of its excipients.

Where it is running

• Lenox Hill Brain Tumor Center — New York, New York, United States

Full record on ClinicalTrials.gov

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