Solid Tumor Treatment with Lenvatinib and Everolimus – Phase II

Study of Lenvatinib in Combination with Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are evaluating the effects of the drug lenvatinib administered in combination with everolimus once daily to participants with recurrent/refractory solid tumors, as classified: Ewing sarcoma, peripheral primitive neuroectodermal tumor, rhabdomyosarcoma, or high-grade glioma. Researchers will be assessing the activity of the drugs in combination, their effects on tumors and how the body processes them.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling participants, ages 2 to 21 years, who have one of the cancers mentioned above.
Males and Females: Ages 2 to 21 years

Requirements

In 4-week cycles, participants will take the study drugs orally, once a day. While taking the study drug, participants will need to visit the clinic for blood draws and examinations. Participants may remain in the study while it is active, unless serious side effects occur or the participant’s tumor worsens.
Visits: 5 in the first cycle, 4 in the second cycle and 3 in each subsequent cycle
Duration: Open ended

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1711)

Primary Investigator

Jean Tersak, MD

Contact Information

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