Last updated on September 2018

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.

TERTIARY 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

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Gregory K. Friedman

Children's Hospital of Alabama
Birmingham, AL United States
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Providence Alaska Medical Center
Anchorage, AK United States
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David L. Becton

Arkansas Children's Hospital
Little Rock, AR United States
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Kaiser Permanente-Anaheim
Anaheim, CA United States
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Kaiser Permanente-Bellflower
Bellflower, CA United States
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Albert Kheradpour

Loma Linda University Medical Center
Loma Linda, CA United States
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Leo Mascarenhas

Children's Hospital Los Angeles
Los Angeles, CA United States
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Kaiser Permanente Los Angeles Medical Center
Los Angeles, CA United States
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Vonda L. Crouse

Children's Hospital Central California
Madera, CA United States
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Carla B. Golden

Children's Hospital and Research Center at Oakland
Oakland, CA United States
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Elyssa M. Rubin

Children's Hospital of Orange County
Orange, CA United States
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Sheri L. Spunt

Lucile Packard Children's Hospital Stanford University
Palo Alto, CA United States
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Marcio H. Malogolowkin

University of California Davis Comprehensive Cancer Center
Sacramento, CA United States
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Kaiser Permanente-San Diego Mission
San Diego, CA United States
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William D. Roberts

Rady Children's Hospital - San Diego
San Diego, CA United States
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Kieuhoa T. Vo

UCSF Medical Center-Mission Bay
San Francisco, CA United States
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Margaret E. Macy

Children's Hospital Colorado
Aurora, CO United States
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Jennifer J. Clark

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, CO United States
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Michael S. Isakoff

Connecticut Children's Medical Center
Hartford, CT United States
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Scott M. Bradfield

Alfred I duPont Hospital for Children
Wilmington, DE United States
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Kaiser Permanente-Capitol Hill Medical Center
Washington, WA United States
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AeRang Kim

Children's National Medical Center
Washington, WA United States
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Emad K. Salman

Golisano Children's Hospital of Southwest Florida
Fort Myers, FL United States
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William B. Slayton

University of Florida Health Science Center - Gainesville
Gainesville, FL United States
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Scott M. Bradfield

Nemours Children's Clinic-Jacksonville
Jacksonville, FL United States
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Enrique A. Escalon

Nicklaus Children's Hospital
Miami, FL United States
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Fouad M. Hajjar

Florida Hospital Orlando
Orlando, FL United States
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Scott M. Bradfield

Nemours Children's Hospital
Orlando, FL United States
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Nemours Children's Clinic - Pensacola
Pensacola, FL United States
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Jonathan L. Metts

Johns Hopkins All Children's Hospital
Saint Petersburg, FL United States
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William T. Cash

Children's Healthcare of Atlanta - Egleston
Atlanta, GA United States
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Straub Clinic and Hospital
Honolulu, HI United States
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Kaiser Permanente Moanalua Medical Center
Honolulu, HI United States
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Kapiolani Medical Center for Women and Children
Honolulu, HI United States
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Eugenia Chang

Saint Luke's Mountain States Tumor Institute
Boise, ID United States
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University of Illinois
Chicago, IL United States
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Ami V. Desai

University of Chicago Comprehensive Cancer Center
Chicago, IL United States
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James R. Egner

Carle on Vermilion
Danville, IL United States
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James R. Egner

Carle Physician Group-Effingham
Effingham, IL United States
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James R. Egner

Carle Physician Group-Mattoon/Charleston
Mattoon, IL United States
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Pedro A. De Alarcon

Saint Jude Midwest Affiliate
Peoria, IL United States
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James R. Egner

Carle Cancer Center
Urbana, IL United States
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James R. Egner

The Carle Foundation Hospital
Urbana, IL United States
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Kamnesh R. Pradhan

Riley Hospital for Children
Indianapolis, IN United States
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Bassem I. Razzouk

Saint Vincent Hospital and Health Care Center
Indianapolis, IN United States
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Vlad C. Radulescu

University of Kentucky/Markey Cancer Center
Lexington, KY United States
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Kerry K. McGowan

Norton Children's Hospital
Louisville, KY United States
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Eastern Maine Medical Center
Bangor, ME United States
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Lafayette Family Cancer Center-EMMC
Brewer, ME United States
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Jason M. Fixler

Sinai Hospital of Baltimore
Baltimore, MD United States
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Christine A. Pratilas

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, MD United States
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Suzanne Shusterman

Massachusetts General Hospital Cancer Center
Boston, MA United States
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Suzanne Shusterman

Dana-Farber Cancer Institute
Boston, MA United States
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Rajen Mody

C S Mott Children's Hospital
Ann Arbor, MI United States
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Roland L. Chu

Wayne State University/Karmanos Cancer Institute
Detroit, MI United States
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Michael K. Richards

Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, MN United States
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Emily G. Greengard

University of Minnesota/Masonic Cancer Center
Minneapolis, MN United States
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Carola A. Arndt

Mayo Clinic
Rochester, MN United States
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Anderson (Andy) B. Collier

University of Mississippi Medical Center
Jackson, MS United States
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Siteman Cancer Center at West County Hospital
Creve Coeur, MO United States
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Keith J. August

The Childrens Mercy Hospital
Kansas City, MO United States
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Barnes-Jewish Hospital
Saint Louis, MO United States
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Robert J. Hayashi

Washington University School of Medicine
Saint Louis, MO United States
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Siteman Cancer Center-South County
Saint Louis, MO United States
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Bethany G. Sleckman

Mercy Hospital Saint Louis
Saint Louis, MO United States
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Siteman Cancer Center at Saint Peters Hospital
Saint Peters, MO United States
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Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, NV United States
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Children's Specialty Center of Nevada II
Las Vegas, NV United States
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Sunrise Hospital and Medical Center
Las Vegas, NV United States
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Summerlin Hospital Medical Center
Las Vegas, NV United States
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Hope Cancer Care of Nevada-Pahrump
Pahrump, NV United States
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Radiation Oncology Associates
Reno, NV United States
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Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, NJ United States
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Clare J. Twist

Roswell Park Cancer Institute
Buffalo, NY United States
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NYU Winthrop Hospital
Mineola, NY United States
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Sharon L. Gardner

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, NY United States
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Alice Lee

Columbia University/Herbert Irving Cancer Center
New York, NY United States
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Philip M. Monteleone

State University of New York Upstate Medical University
Syracuse, NY United States
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Stuart H. Gold

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, NC United States
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James I. Geller

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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John J. Letterio

Rainbow Babies and Childrens Hospital
Cleveland, OH United States
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Cleveland Clinic Foundation
Cleveland, OH United States
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Mark A. Ranalli

Nationwide Children's Hospital
Columbus, OH United States
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Jamie L. Dargart

The Toledo Hospital/Toledo Children's Hospital
Toledo, OH United States
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Rene Y. McNall-Knapp

University of Oklahoma Health Sciences Center
Oklahoma City, OK United States
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Linda C. Stork

Oregon Health and Science University
Portland, OR United States
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Elizabeth Fox

Children's Hospital of Philadelphia
Philadelphia, PA United States
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Jean M. Tersak

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA United States
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Saint Francis Hospital
Greenville, SC United States
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BI-LO Charities Children's Cancer Center
Greenville, SC United States
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Saint Francis Cancer Center
Greenville, SC United States
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Ray C. Pais

East Tennessee Childrens Hospital
Knoxville, TN United States
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Wayne L. Furman

St. Jude Children's Research Hospital
Memphis, TN United States
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The Children's Hospital at TriStar Centennial
Nashville, TN United States
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Stanton C. Goldman

Medical City Dallas Hospital
Dallas, TX United States
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Theodore W. Laetsch

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, TX United States
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El Paso Children's Hospital
El Paso, TX United States
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Texas Tech University Health Sciences Center-El Paso
El Paso, TX United States
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Jodi Muscal

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, TX United States
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Jessica L. Heath

University of Vermont College of Medicine
Burlington, VT United States
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Julie R. Park

Seattle Children's Hospital
Seattle, WA United States
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Judy L. Felgenhauer

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, WA United States
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Gundersen Lutheran Medical Center
La Crosse, WI United States
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Kenneth B. De Santes

University of Wisconsin Hospital and Clinics
Madison, WI United States
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Michael J. Burke

Children's Hospital of Wisconsin
Milwaukee, WI United States
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Kaiser Permanente-Fontana
Fontana, CA United States
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Wendy L. Woods-Swafford

Blank Children's Hospital
Des Moines, IA United States
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Iowa Methodist Medical Center
Des Moines, IA United States
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Iowa Lutheran Hospital
Des Moines, IA United States
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National Institutes of Health Clinical Center
Bethesda, MD United States
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Laura K. Gowans

Beaumont Children's Hospital-Royal Oak
Royal Oak, MI United States
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William C. Petersen

University of Virginia Cancer Center
Charlottesville, VA United States
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Don E. Eslin

Arnold Palmer Hospital for Children
Orlando, FL United States
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Lolie C. Yu

Children's Hospital New Orleans
New Orleans, LA United States
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Huron Medical Center PC
Port Huron, MI United States
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Andrea R. Whitfield

East Carolina University
Greenville, NC United States
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Mariko Sato

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, IA United States
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Steven L. Halpern

Morristown Medical Center
Morristown, NJ United States
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Julie I. Krystal

The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, NY United States
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Eric J. Lowe

Children's Hospital of The King's Daughters
Norfolk, VA United States
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Robert M. Cooper

Kaiser Permanente Downey Medical Center
Downey, CA United States
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Joel A. Kaplan

Carolinas Medical Center/Levine Cancer Institute
Charlotte, NC United States
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Susan G. Kreissman

Duke University Medical Center
Durham, NC United States
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Julio C. Barredo

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, FL United States
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Adonis N. Lorenzana

Ascension Saint John Hospital
Detroit, MI United States
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ProMedica Flower Hospital
Sylvania, OH United States
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