Adult Glioblastoma Clinical Trial
Official title:
Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the therapeutic efficacy of dasatinib in all patients (i.e., stages 1B and 2
combined) with recurrent/progressive glioblastoma (GBM) as measured by 6-month
progression-free survival.
SECONDARY OBJECTIVES:
I. To determine the therapeutic efficacy of dasatinib for stage 1B patients with
recurrent/progressive GBM as measured by a hybrid endpoint of 6-month progression-free
survival OR objective response of (complete response [CR] or partial response [PR]) rate.
II. To determine patient overall survival. III. To determine the toxicity of dasatinib in the
treatment of patients with GBM.
IV. To determine radiographic response rate to treatment. V. To determine patient
progression-free survival. VI. To explore molecular correlates of clinical outcome. VII. To
explore pharmacokinetic correlates of dosing, toxicity, and efficacy.
OUTLINE:
Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression and unacceptable toxicity.
After the completion of study treatment, patients are followed up periodically.
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