Spots Global Cancer Trial Database for Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

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Trial Identification

Brief Title: Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

Official Title: A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

Study ID: NCT00099060

Conditions

Brain and Central Nervous System Tumors

Interventions

lapatinib ditosylate

Study Description

Brief Summary: RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.

Detailed Description: OBJECTIVES: Phase I * Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs). * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Phase II * Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs. * Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive lapatinib as in phase I at the MTD. Patients are followed at 1 month and then periodically for survival. Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months. A total of 15-30 patients will be accrued for the phase II portion of this study within 18 months.