Last updated on March 2019

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. Courses 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

Contact Investigators or Research Sites near you

Start Over

Children's Hospital of Alabama

Birmingham, AL United States
  Connect »

Arkansas Children's Hospital

Little Rock, AR United States
  Connect »

Kaiser Permanente-Anaheim

Anaheim, CA United States
  Connect »

Kaiser Permanente-Bellflower

Bellflower, CA United States
  Connect »

Children's Hospital Los Angeles

Los Angeles, CA United States
  Connect »

UCSF Medical Center-Mission Bay

San Francisco, CA United States
  Connect »

Florida Hospital Orlando

Orlando, FL United States
  Connect »

Nemours Children's Hospital

Orlando, FL United States
  Connect »

Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
  Connect »

Straub Clinic and Hospital

Honolulu, HI United States
  Connect »

University of Illinois

Chicago, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Riley Hospital for Children

Indianapolis, IN United States
  Connect »

Norton Children's Hospital

Louisville, KY United States
  Connect »

Sinai Hospital of Baltimore

Baltimore, MD United States
  Connect »

C S Mott Children's Hospital

Ann Arbor, MI United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

The Childrens Mercy Hospital

Kansas City, MO United States
  Connect »

Barnes-Jewish Hospital

Saint Louis, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

NYU Winthrop Hospital

Mineola, NY United States
  Connect »

Cleveland Clinic Foundation

Cleveland, OH United States
  Connect »

Saint Francis Hospital

Greenville, SC United States
  Connect »

Saint Francis Cancer Center

Greenville, SC United States
  Connect »

El Paso Children's Hospital

El Paso, TX United States
  Connect »

Seattle Children's Hospital

Seattle, WA United States
  Connect »

Kaiser Permanente-Fontana

Fontana, CA United States
  Connect »

Blank Children's Hospital

Des Moines, IA United States
  Connect »

Iowa Methodist Medical Center

Des Moines, IA United States
  Connect »

Iowa Lutheran Hospital

Des Moines, IA United States
  Connect »

University of Virginia Cancer Center

Charlottesville, VA United States
  Connect »

Children's Hospital New Orleans

New Orleans, LA United States
  Connect »

Huron Medical Center PC

Port Huron, MI United States
  Connect »

East Carolina University

Greenville, NC United States
  Connect »

Morristown Medical Center

Morristown, NJ United States
  Connect »

ProMedica Flower Hospital

Sylvania, OH United States
  Connect »

Yale University

New Haven, CT United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.