Solid Tumor Treatment with XL184 – Phase II

Trial of XL184 (Cabozantinib), an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are evaluating the effects of the drug XL184 (cabozantinib) given to patients suffering from certain types of cancers that have returned or did not respond to standard treatments. These cancers include: rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, osteosarcoma, Wilms tumor or other rare tumor, such as medullary thyroid carcinoma, renal cell carcinoma, hepatocellular carcinoma, hepatoblastoma, adrenocortical carcinoma, and other solid tumors including central nervous system tumors. XL184 is a small-molecule inhibitor and has been shown to reduce tumor growth and tumor blood vessel growth in laboratory research and some adult clinical studies.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients, ages 2 to 30 years, with one of the cancers listed in the description above, either recurrent or refractory, or newly diagnosed with no known curative therapy.
Males and Females: Ages 2 to 30 years

Requirements

In 4-week cycles, participants will take the study drug orally on a daily basis. Evaluations, including tests and imaging, will be done after the first 2 cycles. Participants may remain in the study for additional cycles and evaluations as long as their tumors are not getting larger or coming back, and side effects are not too severe.
Visits: Evaluations will be done after cycles 2, 4 and 6, and every third cycle thereafter.
Duration: Open-ended while the study remains active

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1622)
National Cancer Institute
Eisai

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski, MD, MS
412-692-5055