Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05425004

A Phase II Study of Cabozantinib for Patients With Recurrent or Progressive Meningioma

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

24

Participants Needed

3

Research Sites

73 weeks

Total Duration

On this page

Sponsors

B

Baptist Health South Florida

Lead Sponsor

E

Exelixis

Collaborating Sponsor

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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.

AI-Screening

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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

Trial Site Locations

Total: 3 locations

1

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States, 33176

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 100653

Actively Recruiting

3

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

R

Rupesh Kotecha, M.D.

A

Anais Vega

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Phase II study of cabozantinib in patients with progressive glioblastoma: subset analysis of patients naive to antiangiogenic therapy.

Patrick Y Wen, Jan Drappatz, John de Groot...

https://pubmed.ncbi.nlm.nih.gov/29016998