Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic
astrocytoma (AA), comprise the majority of all primary brain tumors in adults. This group
of tumors also exhibits the most aggressive behavior, resulting in median overall survival
durations of only 9-12 months for GBM, and 3-4 years for AA, from initial diagnosis, despite
multimodal treatment approaches. Initial therapy consists of either surgical resection,
external beam radiation or both. The role of adjuvant or concomitant chemotherapy in the
initial therapy of GBM and AA has not, as yet, been clearly defined. Since most of these
patients experience a recurrence after first-line therapy, improvements in both first-line
and salvage therapy are critical to enhancing quality-of-life and prolonging survival. In
August 2003, the U.S. Food and Drug Administration (FDA) granted orphan drug status for
Erlotinib in patients with malignant glioma. Erlotinib (OSI-774) has been shown to be
active in a range of tumors including GBM, AA and non small cell lung cancer. Because of
the promising results in preliminary studies of Erlotinib and because of significant
experience with the safety of the dosages proposed in this study, this study will offer a
safe adjuvant treatment for patients with relapsing recurring glioblastoma or anaplastic
astrocytoma. Therefore, this phase I/II clinical research trial will test the hypothesis
that Erlotinib can be safely used up to a dose of 150 mg bid for 12 cycles to ultimately
enhance survival of patients with relapsed/refractory GBM/AA with particular genetic
alterations including EGFRvIII amplification and PTEN loss.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of twice a day oral 150 mg Erlotinib dosing
duration of the trial
Yes
John A Boockvar, M.D.
Principal Investigator
Weill Medical College of Cornell University
United States: Institutional Review Board
501007705
NCT00301418
March 2006
October 2015
Name | Location |
---|---|
The New York Hospital/ Weill Medical College | New York, New York 10021 |