Clinical Trials

Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

Location:

Rochester, MN, Scottsdale and Phoenix, AZ, Jacksonville, FL

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - Determine the maximum-tolerated dose of dasatinib in combination with bevacizumab in patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. (Phase I*) - Assess the safety and adverse events of this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by progression-free survival at six months. (Phase II) Secondary - Describe any preliminary evidence of antitumor activity. (Phase I*) - Describe the overall toxicity associated with this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by overall survival (Phase II) - Assess the impact of these regimens on the patient's quality of life using FACT-Br (no longer assessed as of 5/18/2009) (newly added as of 2/2/2010). (Phase II) - Assess the time to disease progression. (Phase II) - Assess the safety and toxicity of these regimens in this patient population. (Phase II) - Determine the relationship between tumor biomarkers and clinical outcome of patients treated with these regimens. (Phase II) (exploratory) - Assess the utility of dynamic contrast-enhanced MRI as a predictor of response to these regimens. (Phase II) (exploratory) - To assess the utility of MRI diffusion-weighted images (DWI), and specifically the apparent diffusion coefficient (ADC), as a predictor of response and survival in patients treated with bevacizumab/dasatinib combination treatment. (Phase II) (exploratory) - Bank leftover tissue for future NCCTG studies. (Phase II) (exploratory) NOTE: *Phase I completed. OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of dasatinib followed by a phase II randomized study. Patients are grouped according to study (1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2). Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is determined. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (Phase I completed) Phase II (patients are randomized to 1 of 2 treatment arms): - Arm I: Patients receive bevacizumab as in phase I and dasatinib at the MTD as determined in phase I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive bevacizumab as in phase I and oral placebo once or twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other course (no longer assessed as of 5/18/2009)(newly added as of 2/2/2010). Tissue samples are collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2. After completion of study therapy, patients are followed up periodically for up to 3 years.

Last updated: 02/12/2013

NCT ID:

NCT00892177