A Phase II Study of Pulse Dose Lapatinib with Temozolomide and Radiation Therapy to Treat Newly Diagnosed Glioblastoma

Full Title

Phase II Trial of Pulse Dosing of Lapatinib in Combination with Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients with Newly-diagnosed Glioblastoma Multiforme

Purpose

Radiation therapy and the oral drug temozolomide are standard treatments for newly diagnosed glioblastoma. However, despite this treatment, the cancer continues to grow or comes back. In this study, researchers want to see if adding the drug lapatinib to this treatment enhances the success of therapy.

Lapatinib is already approved to treat breast cancer and is also taken orally (by mouth). It works by blocking two targets in cells that fuel cancer growth when mutated: EGFR and HER2. Its use in this study is considered investigational.

Treatment will consist of various combinations of radiation therapy, lapatinib, and temozolomide for up to two years, followed by lapatinib alone. When lapatinib is taken, it is twice a day, two days a week ("pulse dosing") to achieve adequate concentration of the drug in the brain.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated glioblastoma multiforme.
  • Patients must begin treatment no sooner than 2 weeks and no later than 6 weeks from their surgical biopsy.
  • Patients must be 18 years of age or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jacqueline Stone at 212-639-5006.

Protocol

16-1060

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators