RecruitingPhase 2

Cabozantinib for Patients With Recurrent or Progressive Meningioma

United States24 participantsStarted 2022-06-01

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.
✓. All patients must have developed recurrent disease or progressive disease after receiving standard therapy (e.g., radiation or surgery) \> 6 months ago or have been deemed ineligible to receive these therapies.
✓. Karnofsky Performance Status ≥ 50.
✓. Adequate hematologic function:
✓. Absolute Neutrophil Count ≥ 1.5 x 10\^9 / L without granulocyte colony-stimulating factor support.
✓. Platelet Count ≥ 100 x 10\^9 / L without transfusion.
✓. Hemoglobin ≥ 9 g/dL without transfusion within 7 days prior to screening assessment.
✓. Adequate renal function: ≥ 30 ml/min according to the Cockcroft-Gault formula.

✕. Prior treatment with cabozantinib.
✕. Patients \< 18 years old.
✕. Patients who are pregnant or breast-feeding.
✕. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to the first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
✕. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
✕. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.
✕. Ejection fraction (EF) ≤ 50% by echocardiogram (ECHO). Multi-gated acquisition scan (MUGA) should be obtained to estimate EF if quality of ECHO is insufficient.
✕. Prior history of hypertensive encephalopathy at any time.

Progression free survival (PFS)

Timeframe: 6 months

NCT IDNCT05425004

SponsorBaptist Health South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

Rupesh Kotecha, M.D.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologic (preferred) or radiologic diagnosis of meningioma. All World Health Organization (WHO) grades (I, II and III) are allowed.
✓. All patients must have developed recurrent disease or progressive disease after receiving standard therapy (e.g., radiation or surgery) \> 6 months ago or have been deemed ineligible to receive these therapies.
✓. Karnofsky Performance Status ≥ 50.
✓. Adequate hematologic function:
✓. Absolute Neutrophil Count ≥ 1.5 x 10\^9 / L without granulocyte colony-stimulating factor support.
✓. Platelet Count ≥ 100 x 10\^9 / L without transfusion.
✓. Hemoglobin ≥ 9 g/dL without transfusion within 7 days prior to screening assessment.
✓. Adequate renal function: ≥ 30 ml/min according to the Cockcroft-Gault formula.

✕. Prior treatment with cabozantinib.
✕. Patients \< 18 years old.
✕. Patients who are pregnant or breast-feeding.
✕. Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to the first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
✕. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
✕. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) with 2 weeks before first dose of study treatment.
✕. Ejection fraction (EF) ≤ 50% by echocardiogram (ECHO). Multi-gated acquisition scan (MUGA) should be obtained to estimate EF if quality of ECHO is insufficient.
✕. Prior history of hypertensive encephalopathy at any time.