Last updated on August 2020

Cabozantinib-S-Malate in Treating Younger Patients With Recurrent Refractory or Newly Diagnosed Sarcomas Wilms Tumor or Other Rare Tumors


Brief description of study

This phase II trial studies how well cabozantinib-s-malate works in treating younger patients with sarcomas, Wilms tumor, or other rare tumors that have come back, do not respond to therapy, or are newly diagnosed. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for tumor growth and tumor blood vessel growth.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults.

II. To estimate whether XL184 therapy either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to a historical Childrens Oncology Group (COG) experience or produces an objective response rate.

SECONDARY OBJECTIVES:

I. To further define XL184 related toxicities in pediatric, adolescent and young adult patients.

II. To further define XL184 pharmacokinetics in the pediatric and adolescent patients.

III. To estimate 1-year time to progression, progression free survival (PFS) and overall survival for each stratum, and if feasible to compare to historical controls.

EXPLORATORY OBJECTIVES:

I. To assess the effect of XL184 on patients' immune cell subsets. II. To obtain tumor tissue (snap frozen, formalin-fixed and paraffin-embedded [FFPE] blocks, or unstained slides) from diagnosis, recurrence, or both, for possible future studies.

OUTLINE

Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 6 months for 1 year and then annually for up to 5 years.

Clinical Study Identifier: NCT02867592

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University of Virginia Cancer Center

Charlottesville, VA United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Sinai Hospital of Baltimore

Baltimore, MD United States
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Florida Hospital Orlando

Orlando, FL United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Nemours Children's Hospital

Orlando, FL United States
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Blank Children's Hospital

Des Moines, IA United States
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Norton Children's Hospital

Louisville, KY United States
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Children's Hospital New Orleans

New Orleans, LA United States
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C S Mott Children's Hospital

Ann Arbor, MI United States
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Seattle Children's Hospital

Seattle, WA United States
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Arkansas Children's Hospital

Little Rock, AR United States
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AdventHealth Orlando

Orlando, FL United States
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El Paso Children's Hospital

El Paso, TX United States
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Wayne Memorial Hospital

Goldsboro, NC United States
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MetroHealth Medical Center

Cleveland, OH United States
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Yale University

New Haven, CT United States
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East Carolina University

Greenville, NC United States
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Saint Francis Hospital

Greenville, SC United States
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Saint Francis Cancer Center

Greenville, SC United States
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Kaiser Permanente-Oakland

Oakland, CA United States
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Recruitment Status: Open


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