A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme

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Study design: Multicenter, phase II/III, randomized clinical trial with high-dose sunitinib versus lomustine (CCNU) in patients with recurrent GBM. Hypothesis: Sunitinib, when given in a high-dose, intermittent schedule, may exhibit improved efficacy in patients with recurrent GBM with an acceptable...

Study design: Multicenter, phase II/III, randomized clinical trial with high-dose sunitinib versus lomustine (CCNU) in patients with recurrent GBM. Hypothesis: Sunitinib, when given in a high-dose, intermittent schedule, may exhibit improved efficacy in patients with recurrent GBM with an acceptable toxicity profile, compared to lomustine. Study population: Adult patients with recurrent GBM. Primary objective: - To determine the effect of high-dose sunitinib versus lomustine on six-month progression-free survival (PFS6) in patients with recurrent GBM, using the RANO criteria. Secondary objectives: To determine the effect of high-dose sunitinib on overall survival (OS 9, OS 12) in patients with recurrent GBM. To assess the objective radiological response rate, using the RANO criteria. To assess toxicity, using the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. To assess patient-oriented criteria: steroid use and health-related quality of life (reported by patients and caregivers/relatives). To explore the potential value of blood markers for molecular diagnostics, disease and response monitoring. To explore if MGMT promoter methylation status modulates the response to sunitinib. Treatment: After randomization, 100 patients will be divided equally over two treatment groups and will receive: Group 1 (experimental arm): Sunitinib, 700 mg administered orally every 2 weeks. Group 2 (control arm): Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks. Disease will be assessed by MRI according to an uniform neuro-oncology protocol every 6 weeks for the first 6 months and every 12 weeks until documented progression. Safety profile of both treatment strategies will be assessed separately for each cycle of therapy and every 12 weeks after the end of treatment if adverse effects have not resolved or are newly emerging. Furthermore, quality of life assessment takes place every 6 weeks using questionnaires.

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