Glioblastoma Clinical Trial
Official title:
Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme
Primary objective:
To determine the 6-month progression free survival of patients with recurrent glioblastoma
multiforme (GBM) treated with Erlotinib plus Sirolimus.
Secondary objectives:
To further define the safety and tolerability of Erlotinib plus Sirolimus when administered
to patients with recurrent GBM; and to evaluate progression free survival, radiographic
response and overall survival of patients with recurrent GBM treated with Erlotinib plus
Sirolimus.
The primary objective of this study will be to determine the 6-month progression free
survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.
This is an exploratory, single-arm, phase II study designed to assess the anti-tumor
activity of a combinatorial regimen consisting of Erlotinib plus Sirolimus among patients
with recurrent GBM. The combinatorial regimen of Erlotinib plus Sirolimus is rationally
designed to simultaneously inhibit upstream (EGFR) and downstream (mTOR) mediators of
Phosphatidylinositide 3-kinase/Protein Kinase B (PI3/AKT) signaling. In a recently completed
phase I study, we determined that an EGFR inhibitor (Gefitinib) can be safely combined with
Sirolimus at dose levels that are routinely used in the monotherapy setting. Therefore, the
primary endpoint of this study is the probability of progression-free survival at 6 months
among recurrent GBM patients treated with standard doses of Erlotinib plus Sirolimus. An
important secondary objective is to further assess the safety of Erlotinib and Sirolimus for
patients with recurrent GBM.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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