A Phase II Study of Cabozantinib for Patients With Recurrent or Progressive Meningioma
A Phase II Study of Cabozantinib for Patients with Recurrent or Progressive Meningioma
• 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.
• Adequate hepatic function including:
∙ Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
‣ Aspartate transaminase (AST) ≤ 3 x ULN without liver metastasis.
‣ Alanine transaminase (ALT) ≤ 3 x ULN without liver metastasis.
‣ AST or ALT ≤ 5 x ULN for patients with liver metastasis.
‣ Patients with known Gilbert's syndrome may be included if total bilirubin ≤ x 3 ULN.
• Patients must have measurable disease by iRANO criteria
• Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including:
∙ Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons.
‣ Documented hysterectomy or bilateral oophorectomy surgery.
‣ Medically confirmed ovarian failure.
‣ Sexually active participants and their partners must agree to use medically. accepted methods of contraception during the study and for 4 months after discontinuing study treatment
• Recovery of baseline CTCAE v5.0 Grade ≤1 toxicity related to prior study treatments unless adverse events are clinically non-significant per investigator's discretion and/or stable on supportive therapy if needed.
⁃ Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures.
⁃ Serum albumin ≥ 2.8 g/dL.
⁃ Prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test \< 1.3x the laboratory ULN.