There are very few established treatments for ependymomas that are recurrent (regrowing) after initial surgery and radiation treatment. Fortunately, recent laboratory investigations may provide some guidance in developing new treatment regimens. Many ependymomas, including those occurring in adults, have specific changes in molecular pathways that help the tumor cell survive and proliferate. Based on studies performed by CERN member Richard Gilbertson, the most prominent abnormalities are in the ERBB1 (also known as epidermal growth factor receptor) and ERBB2 (also known as Her-2) pathways. Furthermore, most ependymomas were found to express the MGMT protein which causes resistance to most chemotherapy agents. We designed the current clinical trial to target (attack) both the important molecular pathways and the chemotherapy resistance.

About this trial:

This clinical trial combines 2 drugs: lapatinib and temozolomide. Lapatinib is an oral drug, taken on a daily basis and works by blocking both the ERBB1 and the ERBB2 pathways. Temozolomide is a well established chemotherapy specifically designed for brain tumors as it crosses the blood-brain barrier. When provided using an intensive schedule, the temozolomide may inhibit the MGMT resistance, increasing the chemotherapy response by the tumor. This is the rational for administering the oral temozolomide on a 7 day on, 7 day off regimen.

Purpose:

The objective of the clinical trial is to measure the effectiveness of this regimen in patients with recurrent ependymoma, including low grade and anaplastic tumors occurring in either the brain or the spinal cord. The study will also examine the tumor tissue to determine if there are specific markers that predict the effectiveness of this treatment regimen.

Trial process:

Patients who are enrolled on the trial will receive the lapatinib free of charge and will be provided a prescription for the temozolomide. Evaluations looking at effectiveness will be performed every 2 months and the treatment is scheduled to continue for 1 year, although patients with continued response may be able to continue for a second year.

Click here to view a very helpful PDF chart that details the process for this trial. This chart breaks down and explains the multiple phases/cycles for this specific trial.

Eligibility criteria:

1. Proven ependymoma or anaplastic ependymoma. Central review of pathology is required.
2. Age 18 years or older
3. Able to undergo MRI scans
4. Normal bone marrow, kidney and liver function
5. No active heart disease, active infections or problems with wound healing.
6. Not pregnant or breast feeding

If you have any questions about this Clinical Trial please contact us.