A Phase I Study of Olaratumab Alone and with Chemotherapy in Children with Solid Tumors

Full Title

A Phase 1, Open-Label, Dose-Escalation Study of Olaratumab as a Single Agent and in Combination with Doxorubicin, Vincristine/Irinotecan, or High-Dose Ifosfamide in Pediatric Patients with Relapsed or Refractory Solid Tumors (I5B-MC-JGDN)

Purpose

Olaratumab is an anticancer drug used to treat soft tissue sarcoma in adults. In this study, researchers want to find the highest dose of olaratumab that can be given safely in children with solid tumors, both when given alone and in combination with chemotherapy drugs.

Olaratumab targets a protein called PDGFR-alpha, which is overproduced in certain cancers and can drive cancer metastasis. Investigators in this study are combining olaratumab with doxorubicin, with vincristine/irinotecan, or with high-dose ifosfamide. All medications in this study 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 a solid tumor that has come back or continued to grow despite standard therapy or for which no standard therapy exists.
  • Patients must be candidates for treatment with doxorubicin, with vincristine/irinotecan, or with high-dose ifosfamide.
  • Patients must recover from the side effects of prior therapies before entering the study.
  • This study is for patients under age 18.

For more information about this study and to inquire about eligibility, please contact Dr. Emily Slotkin at 212-639-8856.

Protocol

16-1339

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Locations