Cabozantinib for Patients With Recurrent or Progressive Meningioma

  • STATUS
    Recruiting
  • End date
    Apr 28, 2024
  • participants needed
    24
  • sponsor
    Baptist Health South Florida
Updated on 8 July 2022
platelet count
renal function
hysterectomy
measurable disease
karnofsky performance status
neutrophil count

Summary

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

Details
Condition Meningioma
Treatment Cabozantinib
Clinical Study IdentifierNCT05425004
SponsorBaptist Health South Florida
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic (preferred) or radiologic diagnosis of meningioma. All WHO grades (I, II and III) are allowed
All patients must have developed recurrent disease or progressive disease after receiving standard therapy (eg, radiation or surgery) >6 months ago or have been deemed ineligible to receive these therapies
Karnofsky Performance Status ≥50 (Appendix 1)
Adequate Hematologic Function
(1) Absolute Neutrophil Count ≥ 1.5 x 10^9 / L without granulocyte colony-stimulating
factor support
(2) Platelet Count ≥ 100 x 10^9 / L without transfusion. (3) 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 (Appendix
) 6. Adequate Hepatic Function including
(1) Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (2) AST ≤ 3 x upper limit of normal
(ULN) without liver metastasis (3) ALT ≤ 3 x upper limit of normal (ULN) without liver
metastasis (4) AST or ALT ≤ 5 x upper limit of normal (ULN) for patients with liver
metastasis (5) Patients with known Gilbert's syndrome may be included if total bilirubin ≤
x 3 ULN 7. Patients must have measurable disease by iRANO criteria (Section [13.2.2.1](telnet://13.2.2.1)) 8
Women of childbearing potential must have negative serum pregnancy testing at screening
All women will be considered childbearing potential unless meeting criteria including
(1) Achieved post-menopausal status as defined by cessation of regular menses for at least
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
(2) Documented hysterectomy or bilateral oophorectomy surgery (3) Medically confirmed
ovarian failure (4) 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 (Section 11.4)
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 12. (PT)/INR or partial thromboplastin time (PTT) test < 1.3x
the laboratory ULN

Exclusion Criteria

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 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) within 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 10. History of congenital QT
syndrome. 11. Corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms
within 14days of study registration (Appendix 6). If initial QTcF is >500 ms, two
additional EKGs separated by at least 3 minutes should be performed, and if average of
these consecutive results is QTcF is ≤ 500 ms, patient is eligible
Unstable cardiac arrhythmia within 6 months prior to study registration date
Urine Protein-to-Creatinine ratio (UPCR) >1 mg/mg or 24-hour urine protein > 1 gram
(Appendix 5) 14. History of bleeding diathesis or significant unexplained coagulopathy (eg
in the absence of anticoagulation)
Clinical signs or symptoms of gastrointestinal obstruction requiring parenteral
hydration, nutrition or feeding tube
Uncontrolled effusion management (pleural effusion, pericardial effusion or ascites)
requiring recurrent drainage procedures
Active infection requiring parenteral antibiotic therapy. 18. History of either
positive HCV RNA viral load or detectable anti-HCV antibody; HBV infection with HBV surface
antigen detection and/or positive HBV DNA viral load
Serious non-healing wound, ulcer, or bone fracture requiring intervention within 28
days prior to study registration date
Known hypersensitivity to cabozantinib or any component in formulation. 21. Inability
to swallow capsules, known intolerance to cabozantinib or its excipients, known
malabsorption syndrome, or other conditions which impair intestinal absorption
Other severe acute or chronic medical conditions, which may increase study risk per
treating investigator's discretion
Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin
inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet
inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following
a. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable
guidelines) and low-dose low molecular weight heparins (LMWH)
b. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors
rivaroxaban, edoxaban, or apixaban in subjects who are on a stable dose of the
anticoagulant for at least 1 week before first dose of study treatment without clinically
significant hemorrhagic complications from the anticoagulation regimen or the tumor
The subject has uncontrolled, significant intercurrent or recent illness including, but
not limited to, the following conditions
Cardiovascular disorders
Congestive heart failure New York Heart Association Class 3 or 4, unstable angina
pectoris, serious cardiac arrhythmias
Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg
systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or
other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary
embolism) within 6 months before first dose of study treatment
Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are
allowed if stable, asymptomatic, and treated with a stable dose of permitted
anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of
study treatment
Gastrointestinal (GI) disorders including those associated with a high risk of
perforation or fistula formation
The subject has evidence of any concurrent malignancy invading the GI tract, active
peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease)
diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute
pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric
outlet obstruction
Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess
within 6 months before first dose of study treatment
Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of
study treatment
Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml)
of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within
weeks before first dose of study treatment
Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease from
another malignancy
Other clinically significant disorders that would preclude safe study participation
Serious non-healing wound/ulcer/bone fracture
Uncompensated/symptomatic hypothyroidism
Moderate to severe hepatic impairment (Child-Pugh B or C). 28. Major surgery (e.g
laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2
weeks before first dose of study treatment. Minor surgeries within 10 days before
first dose of study treatment. Subjects must have complete wound healing from major
surgery or minor surgery before first dose of study treatment. Subjects with
clinically relevant ongoing complications from prior surgery are not eligible
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