Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Phase I Objectives:
-To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat +
erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and
anaplastic gliomas.
Phase II Objectives:
Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib +
temozolomide in patients with recurrent glioblastoma multiforme as progression free survival
using a two arm adaptive randomization phase II trial design.
Secondary: To determine the radiological response, progression free survival (PFS) at 6
months, overall survival and unexpected toxicity in the two treatment arms; and to obtain
exploratory data regarding histone 3 and 4 acetylation, treatment related changes in the
epidermal growth factor receptor (EGFR) pathway proteins, and changes in e-cadherin and
vimentin expression (mRNA /protein) levels in tumor tissue and peripheral monocytes in a
subset of surgical patients.