A Phase I Study of Lenvatinib plus Everolimus in Patients with Recurrent or Persistent Pediatric Solid Tumors, including Brain Tumors

Full Title

A Phase 1/2 Study of Lenvatinib in Combination with Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Purpose

The purpose of this study is to find the highest doses of the drugs lenvatinib and everolimus that can be given together in children and adolescents with solid tumors that have come back or continued to grow despite treatment. Lenvatinib works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Everolimus inhibits a molecule called mTOR, which helps cancer cells grow.

Lenvatinib is approved for treating thyroid and kidney cancers, and everolimus is used to treat a number of cancers; their use in this study is considered investigational. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients age 2-21 years.
  • Patients must have persistent or recurrent solid tumors, including brain tumors, that have continued to grow despite treatment. Patients with hepatoblastoma or lymphoma may not participate.
  • Patients must recover from the serious side effects of prior therapies before entering the study.

For more information and to inquire about eligibility for this study, please contact Dr. Filemon Dela Cruz at 212-639-3964.

Protocol

18-123

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators