Actively Recruiting
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
308 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
A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
CONDITIONS
Official Title
Cabozantinib for Patients With Recurrent or Progressive Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or radiologic diagnosis of meningioma of any WHO grade (I, II, or III)
- Recurrent or progressive disease after standard therapy more than 6 months ago or ineligible for such therapies
- Karnofsky Performance Status of 50 or higher
- Adequate blood cell counts (ANC ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hemoglobin ≥ 9 g/dL)
- Adequate kidney function (≥ 30 mL/min by Cockcroft-Gault formula)
- Adequate liver function with specified limits on bilirubin and liver enzymes
- Measurable disease by RANO meningioma criteria
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for 4 months after the study
- Recovery from prior treatment toxicities to Grade 1 or less unless clinically non-significant
- Willingness and ability to follow the study protocol and procedures
- Serum albumin ≥ 2.8 g/dL
- Prothrombin time/INR or PTT less than 1.3 times the laboratory upper limit of normal
You will not qualify if you...
- Prior treatment with cabozantinib
- Under 18 years of age
- Pregnant or breastfeeding
- Any other active malignancy requiring treatment within 3 years except certain cured skin or in situ cancers
- Received systemic anticancer therapy within 4 weeks before study treatment
- Received small molecule kinase inhibitors within 2 weeks before study treatment
- Ejection fraction ≤ 50%
- History of hypertensive encephalopathy
- History of congenital QT syndrome
- Corrected QT interval > 500 ms within 14 days of registration
- Unstable cardiac arrhythmia within 6 months prior to registration
- Urine protein-to-creatinine ratio >1 mg/mg or 24-hour urine protein >1 gram
- History of bleeding disorders or significant unexplained coagulopathy
- Gastrointestinal obstruction needing parenteral support
- Uncontrolled effusions requiring repeated drainage
- Active infection needing intravenous antibiotics
- Positive hepatitis B or C infection
- Recent serious non-healing wounds, ulcers, or fractures
- Known allergy or intolerance to cabozantinib or its ingredients
- Inability to swallow capsules or conditions impairing absorption
- Other severe medical conditions increasing risk per investigator
- Use of certain anticoagulants except specified allowed medications
- Uncontrolled significant illnesses including serious heart conditions or uncontrolled hypertension
- Recent stroke, heart attack, or thromboembolic event within 6 months
- Gastrointestinal disorders with high risk of perforation or fistula within 6 months
- Significant recent bleeding within 12 weeks
- Cavitating lung lesions or airway disease from another cancer
- Clinically significant disorders precluding safe participation
- Major surgery within 2 weeks or minor surgery within 10 days before study treatment without complete healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
R
Rupesh Kotecha, M.D.
CONTACT
A
Anais Vega
CONTACT
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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