What is cabozantinib studying for meningioma?

Cabozantinib is being studied for adults with recurrent or progressive meningioma to evaluate its effects on tumor progression and patient outcomes. The study aims to understand how cabozantinib impacts survival, tumor response, and quality of life for people with this condition. Baptist Health South Florida is leading this research to improve treatment options.

Who may be eligible for this meningioma clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of meningioma that has recurred or progressed after standard treatments may be eligible. Participants must have adequate organ function and be able to take oral medication. People who have had cabozantinib before or are pregnant cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this meningioma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses are not guaranteed to be covered and may vary by participant. Participants should plan accordingly for any costs related to transportation or lodging.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05425004

Phase 2 Study of Cabozantinib for Adults With Recurrent or Progressive Meningioma

Led by Baptist Health South Florida · Updated on 2026-05-14

Participants Needed

Research Sites

73 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate cabozantinib in adults with recurrent or progressive meningioma, a type of brain tumor. It focuses on patients who have experienced disease recurrence or progression after standard treatments like surgery or radiation, or those ineligible for such therapies. The study is a Phase II trial designed to assess how well cabozantinib works and is tolerated in this patient group. Participants will take cabozantinib tablets orally at a starting dose of 60 mg once daily on a continuous 28-day cycle. The study doctor may adjust the dose based on side effects, lowering it to 40 mg, 20 mg daily, or 20 mg every other day if needed. Treatment continues as long as participants benefit and do not experience significant toxicities. Throughout the study, participants will be monitored regularly to assess progression-free survival at 6 months as the primary outcome. Additional outcomes include overall survival, tumor response, adverse events, and quality of life over 2 years. The study involves scheduled visits with laboratory tests, imaging, and safety assessments to track health and treatment effects, with participation lasting as long as treatment is continued or until disease progression or unacceptable side effects occur.

CONDITIONS

Brief Title

Cabozantinib for Patients With Recurrent or Progressive Meningioma

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Cabozantinib (Trial Regimen)	Bevacizumab + Everolimus (Current-care Combination)
Treatment regimen and clinical context	Cabozantinib is an oral tyrosine kinase inhibitor targeting MET and VEGFR supplied as film-coated tablets, given once daily. The trial studies this regimen in adults with recurrent or progressive meningioma of any WHO grade who have failed or cannot receive standard treatments such as surgery or radiation.	Bevacizumab plus everolimus is an intravenous and oral combination used off-label for refractory, progressive meningioma after standard therapy failure. Evidence from a recent phase II trial supports its use in a similar population.
Intended clinical purpose	Investigational treatment aimed at controlling tumor growth and delaying disease progression in adults with recurrent or progressive meningioma.	Intended to control tumor progression and offer symptomatic management for refractory progressive meningioma not responding to prior therapies.
Administration and dosing	Cabozantinib is taken orally once daily at a starting dose of 60 mg, with possible dose reductions according to side effects.	Bevacizumab is given as intravenous infusions while everolimus is taken orally, both administered according to the combination regimen used in the referenced phase II study.
Evidence maturity and published support	Results for cabozantinib in progressive meningioma are not yet published; this trial is ongoing with primary outcome measuring progression-free survival at 6 months.	Published phase II study of bevacizumab and everolimus showed disease control rates and progression-free survival in patients with refractory meningioma, but interpretation is limited by open-label design and population heterogeneity.
Key limitations and uncertainties	Single-arm study without a randomized control group; efficacy and safety results for cabozantinib in meningioma are not yet established, and interpretation will rely on post-study publication.	Evidence for bevacizumab plus everolimus comes from open-label, phase II studies rather than randomized controlled trials; population heterogeneity and variation in prior treatments may affect interpretation.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologic or radiologic diagnosis of meningioma (any WHO grade I, II, or III).
Recurrent or progressive disease after standard therapy over 6 months ago or ineligibility for such therapies.
Karnofsky Performance Status of at least 50.
Adequate blood cell counts without recent transfusions.
Adequate kidney function (creatinine clearance ≥ 30 mL/min).
Adequate liver function within specified laboratory limits.
Measurable disease by RANO meningioma criteria.
Negative pregnancy test for women of childbearing potential.
Use of effective contraception during and 4 months after treatment if sexually active.
Recovery to baseline or mild toxicity from prior treatments.
Willingness and ability to follow study protocol and visits.
Serum albumin ≥ 2.8 g/dL.
Normal blood clotting test results within laboratory limits.

You will not qualify if you...

Prior treatment with cabozantinib.
Under 18 years old.
Pregnant or breastfeeding.
Other active cancers requiring treatment within 3 years, except certain cured skin or bladder cancers.
Recent systemic anticancer therapy within 4 weeks.
Recent kinase inhibitor therapy within 2 weeks.
Poor heart function (ejection fraction ≤ 50%) or unstable heart conditions.
History of hypertensive encephalopathy or congenital QT syndrome.
Prolonged QT interval over 500 ms.
Unstable cardiac arrhythmias within 6 months.
Significant proteinuria or bleeding disorders.
Gastrointestinal obstruction or uncontrolled effusions.
Active infections requiring intravenous antibiotics.
Viral hepatitis infection.
Serious non-healing wounds or fractures.
Allergies or intolerance to cabozantinib or its ingredients.
Inability to swallow capsules or malabsorption issues.
Severe medical conditions increasing study risk.
Use of certain anticoagulants not allowed by protocol.
Uncontrolled illnesses including severe heart failure, uncontrolled hypertension, recent heart attack or stroke.
Gastrointestinal diseases with risk of perforation or fistula.
Significant recent bleeding or pulmonary lesions.
Moderate to severe liver impairment.
Recent major surgery or ongoing complications from surgery.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Ongoing 28-day cycles until disease progression or unacceptable side effects

Participants will self-administer cabozantinib 60 mg daily by mouth on a continuous 28-day schedule. Participants will continue to take this medication as long as they are deriving benefit from it without significant treatment-related toxicities.

Regular visits for monitoring during treatment