Clinical Trials

Sorafenib and Temsirolimus in Treating Patients With Recurrent Glioblastoma

Location:

Trial status:

Inactive

Why is this study being done?

PRIMARY OBJECTIVES: I. Establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs). (Phase I [closed to accrual as of 11/21/07]) II. Define the safety profile of temsirolimus and sorafenib in these patients. (Phase I [closed to accrual as of 11/21/07]) III. Assess the evidence of antitumor activity. (Phase I [closed to accrual as of 11/21/07])Assess the efficacy, as measured by progression-free survival, of temsirolimus and sorafenib in patients with recurrent glioblastoma not receiving EIACs. (Phase II) IV. Assess the safety and toxicities of this regimen in these patients. (Phase II) SECONDARY OBJECTIVES: I. Correlate tumor and blood biomarkers with clinical outcome of patients treated with temsirolimus and sorafenib. II. Evaluate tumor tissue specimens for evidence of bioactivity of these agents. OUTLINE: This is a multicenter, phase I (closed to accrual as of 11/21/07), dose-escalation study of temsirolimus followed by a phase II open-label study. PHASE I: Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. (closed to accrual as of 11/21/07) Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus 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 are assigned to 1 of 3 treatment groups. GROUP 1: Patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD. (patients not undergoing surgery) GROUP 2: Patients receive oral sorafenib twice daily on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. (patients undergoing surgery) After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD. GROUP 3: Patient receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD. (patients who have received prior anti-VEGF therapy and are not undergoing surgery) Biopsy or resected tissue and blood are collected prior to treatment (usually at diagnosis) and analyzed for biomarkers. After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

Last updated: 03/26/2013

NCT ID:

NCT00329719