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SJELIOT: Phase I Study of a CHK1/2 Inhibitor Therapy in Combination with Chemotherapy for Children and Adolescents with Refractory or Recurrent Medulloblastoma Brain Tumors

About this study

Medulloblastoma is the most common brain cancer in children. While most children with medulloblastoma get better with standard treatments like surgery, radiation or medication, some children do not respond to treatment. Other children may get better at first, but the cancer comes back later.

This clinical trial will test an experimental drug treatment for children and adolescents with medulloblastoma tumors that did not get better with treatment or came back after treatment. The experimental drug is called prexasertib. Research in the lab suggests prexasertib may help fight certain kinds of medulloblastoma tumors. However, prexasertib has not been proven to work in people with these types of tumors.

Before you can participate in this study, we need to find out what type of medulloblastoma tumor you have. We will do this by looking at a sample of your tumor. This is called the screening part of the study.

You may be eligible for the treatment part of the study if the screening shows your tumor is one of four medulloblastoma subtypes: Group 3, Group 4, Sonic Hedgehog (SHH) or Indeterminate.

If you qualify for the treatment part of the trial, you will be given prexasertib along with one of two standard chemotherapy drugs: cyclophosphamide or gemcitabine. Chemotherapy is strong anti-cancer medicine. These drugs will be given through a vein in the arm. You may continue to receive this medicine for up to 2 years unless you develop serious side effects or your tumor worsens.

Throughout the study, you will have tests and procedures to check for side effects, and to see how your tumor is responding to the treatment.

You may or may not benefit from taking part in this study. However, information learned from this study may help future patients with cancer.

Purpose of this clinical trial

The main goal of this study is to find the highest, safe dose of prexasertib that can be given with chemotherapy without causing severe side effects. Researchers also want to find out if prexasertib combined with chemotherapy is a helpful treatment for medulloblastoma tumors.

Eligibility overview

  • Recurrent, refractory or progressive medulloblastoma
  • At least 1 year old and younger than 25 years old

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

St. Jude ELIOT: Phase 1 Evaluation of LY2606368, a Molecularly-Targeted CHK1/2 Inhibitor Therapy, in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Refractory or Recurrent Group 3/Group 4 or SHH Medulloblastoma Brain Tumors

Study goal:

The main goal of this study is to find the highest, safe dose of prexasertib that can be given with chemotherapy without causing severe side effects. Researchers also want to find out if prexasertib combined with chemotherapy is a helpful treatment for medulloblastoma tumors.

Diagnosis:

Medulloblastoma, brain tumors

Age:

1 year to 24 years

Clinical trials categories:

Childhood Cancer Medulloblastoma Brain Tumors

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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