Research

Tumor and Leukemia Treatment with MLN8237 - Phase II/III

Use of MLN8237 in Pediatric Patients With Relapsed or Refractory Solid Tumors or Acute Lymphoblastic Leukemia

Protocol Description

This is a Phase I/II Children's Oncology Group study to determine dosing requirements for the drug MLN8237 in treating young patients with relapsed or refractory solid tumors or acute lymphoblastic leukemia. The drug stops the function of Aurora A kinase, an enzyme found in human cells and which is found in abundance in certain cancerous tumor cells. Researchers believe that a drug that decreases the effectiveness of Aurora A should help to slow tumor growth.

Eligibility Criteria

Patients of both genders, ages 1 to 21, who have been diagnosed with a recurrent or progressive solid tumor or leukemia that have been unable to be cured by any known standard treatment will be asked to participate.
Males: Ages 1 to 21
Females: Ages 1 to 21

Requirements
Patients will be given MLN8237 orally once a day for 7 days followed by a 14-day rest period. Patients may receive this course of treatment for up to 2 years. Blood and other samples will be taken periodically throughout the study.
Frequency of visits: Weekly for first course; every 2 to 4 weeks thereafter
Duration: Up to 2 years

Status: Open for Enrollment

Sources of Support
Children’s Oncology Group
National Cancer Institute

Additional Resources
Study description at National Institutes of Health
Children’s Oncology Group CureSearch
National Cancer Institute