A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial, Infratentorial and Spinal Cord Ependymoma
The goal of this clinical research study is to learn if lapatinib when given in combination with temozolomide can help to control ependymoma that has come back after treatment. The safety of this combination will also be studied.
Treatment Location: N/A
Primary Objective To determine the efficacy of the combination of temozolomide and lapatinib in recurrent brain ependymoma and anaplastic ependymoma as measured by median progression-free survival. Secondary Objectives To determine the efficacy of the combination of lapatinib and temozolomide as measured by objective response in patients with measurable disease. To determine the adverse event profile and tolerability of the combination of lapatinib and temozolomide in patients with recurrent ependymoma To correlate response, either by objective response or progression-free survival at 12 months with EGFR expression, PTEN expression and MGMT gene promoter methylation status. Determine the efficacy of the combination of lapatinib and temozolomide in spinal cord ependymoma as a component of a pilot study. To evaluate longitudinal changes in symptom measures and determine the impact of the therapy on these parameters. To measure symptom burden over the course of therapy to evaluate differences between patients individual symptom severity, overall mean symptom severity, and difference in scores on the interference items between responders and non-responders. To describe the variability of symptom severity longitudinally over the treatment course and follow-up period.
IRB Review and Approval Date: 12/12/2008
Recruitment Status: Closed
Projected Accrual: N/A