A Phase II Study of Denosumab in Adolescents and Adults with Recurrent or Persistent Osteosarcoma

Full Title

Phase 2 Study of Denosumab (IND#127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma (COG AOST1321) (CIRB)

Purpose

Denosumab is a drug approved for treating inoperable giant cell cancer of the bones in adults and adolescents with mature bones, for thinning bones in women, and for bone metastases in adults. In this study, researchers are evaluating the safety and effectiveness of denosumab treatment in patients with osteosarcoma (bone cancer) that has come back after therapy or stopped responding to treatment, including adolescents with bones that have not yet matured.

Denosumab works by decreasing the breakdown of bone and increasing bone strength and thickness. Laboratory studies show that it is active against osteosarcoma. It is 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 has come back or continued to grow despite therapy.
  • Patients must be at least age 11 and under age 50.
  • Female patients must have a bone age of 12 years or greater and males must have a bone age of 14 or greater.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Chou at 212-639-6057.

Protocol

16-409

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Locations