A Phase I/II Study of Prexasertib, Irinotecan, and Temozolomide in People with Persistent or Relapsed Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

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Full Title

A Phase I/II Dose Escalation/Dose Expansion Study of Prexasertib in Combination with Irinotecan and Temozolomide in Patients with Relapsed or Refractory Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

Purpose

The purpose of this study is to see if the investigational drug prexasertib is a safe and effective treatment for people with persistent or recurrent desmoplastic small round cell tumor (DSRCT) or rhabdomyosarcoma when given in combination with the standard drugs irinotecan and temozolomide. Researchers will evaluate different doses of prexasertib plus irinotecan and temozolomide to find the highest dose that can be given safely.

Prexasertib is a type of medication called a “checkpoint kinase inhibitor.” It works by stopping cancer cells from repairing damage to themselves and their DNA (genetic material). This may lead to the death of cancer cells. All medications used 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 DSCRT or rhabdomyosarcoma that continues to grow or came back despite standard treatment.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • This study is for patients age 12 months and older.

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

Protocol

19-120

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators