Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
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) Please see the Arms section for the Phase II treatment regimens. OBJECTIVES: PRIMARY OBJECTIVES: 1. Determine the maximum tolerated dose (MTD) of dasatinib in combination with bevacizumab in high grade glioma patients. (Phase I) 2. To assess the safety and adverse events of the dasatinib in combination with bevacizumab in this patient population. (Phase I) 3. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by progression free survival at six months and compare it with the efficacy of bevacizumab alone. (Phase II) SECONDARY OBJECTIVES: 1. To describe the overall toxicity associated with the dasatinib/bevacizumab combination. (Phase I) 2. To describe any preliminary evidence of antitumor activity. (Phase I) 3. To assess the time to disease progression. (Phase II) 4. To assess the safety and toxicity of the bevacizumab combination with dasatinib in this patient population. (Phase II) 5. To estimate the efficacy of the bevacizumab combination with dasatinib in recurrent glioblastoma multiforme as measured by overall survival time and compare it with the efficacy of bevacizumab alone. (Phase II) 6. To assess the impact of the treatment on the patient's quality of life (QOL) using the overall score from the FACT-Br (Phase II)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
