This pilot phase II trial studies how well cabozantinib s-malate works in treating patients
with pheochromocytomas or paragangliomas that have spread from the primary site to other
places in the body and cannot be removed by surgery. Cabozantinib s-malate may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking
the growth of new blood vessels necessary for tumor growth.
I. To estimate best overall response rate in patients with measurable disease determined by
computed tomography (CT) or magnetic resonance imaging (MRI).
I. To estimate progression-free survival at 1-year. II. To correlate blood pressure control
and change/discontinuation of antihypertensive medications with tumor responses.
III. To correlate symptomatology evaluation by the MD Anderson Symptom Inventory (MDASI) with
IV. To correlate plasma metanephrines and chromogranin A with tumor responses. V. To
correlate plasma C-reactive protein and interleukin-6 with symptoms and tumor responses.
VI. Toxicity assessment by the Common Terminology Criteria for Adverse Events (CTCAE).
VII. To correlate both c-MET expression by immunohistochemistry (IHC) as well as MET
amplification by fluorescence in situ hybridization (FISH) in archived samples and correlate
these biomarkers with overall prognosis and responsiveness to cabozantinib (cabozantinib
I. Best overall response rate in patients with bone metastases only (8 patients) as
determined by fludeoxyglucose F 18 positron emission tomography/computed tomography
II. FDG-PET/CT maximum standard uptake value (SUVmax), advanced volumetric measures including
peak standard uptake value (SUVpeak), metabolic tumor volume (MTV), and total lesion
III. Time to skeletal related events. IV. Incidence of skeletal related events at 4 months
and one year. V. Markers of bone turnover (bone specific alkaline phosphatase and C-terminal
Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses
repeat every 4 weeks through week 24 and then every 8 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30-37 days.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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