A Phase II Study of Ifosfamide and Etoposide with and without Lenvatinib in Children, Adolescents, and Young Adults with Recurrent or Persistent Osteosarcoma

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Full Title

A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children,Adolescents and Young Adults with Relapsed or Refractory Osteosarcoma (OLIE)

Purpose

Ifosfamide and etoposide are chemotherapy drugs used to treat a form of bone cancer called osteosarcoma. In this study, researchers want to see if giving the anticancer drug lenvatinib with ifosfamide and etoposide is more effective than ifosfamide and etoposide alone in children, adolescents, and young adults with osteosarcoma that has come back or continued to grow despite prior treatment. Patients will be randomly assigned to receive either lenvatinib with ifosfamide and etoposide or ifosfamide and etoposide alone.

Lenvatinib works by inhibiting the growth of the blood vessels that tumors need to grow and spread. It is used to treat thyroid, kidney, and liver cancers; its use in this study is investigational. It is taken orally (by mouth). Ifosfamide and etoposide are given intravenously (by vein).

Eligibility

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

  • Patients must have osteosarcoma that came back or kept growing after one or two prior regimens of chemotherapy.
  • At least 4 weeks must pass between the completion of prior treatment and receipt of the study therapy.
  • This study is for patients age 2 to 25.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Julia Glade Bender at 212-639-2972.

Protocol

20-283

Phase

II

Disease Status

Relapsed or Refractory

Investigator