A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas
There is a growing belief that angiogenesis inhibition represents a potentially promising,
novel therapeutic approach to highly vascular solid tumors like malignant gliomas.
Thalidomide and Peg-Intron (IFN - Interferon) are attractive drugs to use in combination to
test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven
activity as single agents in patients with malignant gliomas and their spectrum of largely
Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects
of low dose, continuous IFN administration, we are interested in evaluating the use of
pegylated IFN in combination with thalidomide. Thus, we are proposing a phase II trial of
pegylated IFN with thalidomide in patients with recurrent gliomas.
To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with
thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of
progression-free survival compared to historical controls.
A secondary endpoint in this trial is to determine the response rate associated with the
combination therapy in each of the two strata and to evaluate and document all toxicities
from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in
this patient population.
Patients with histologically proven supratentorial malignant primary gliomas will be
eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic
astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma
(AMO), or malignant astrocytoma NOS (not otherwise specified).
Patients must not have received prior therapy with Peg-Intron or Thalidomide.
Patients will be treated with weekly PEG-Intron plus daily oral thalidomide. All patients
will be treated for 6 weeks following which patients will have a repeat MRI scan to assess
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy. Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles.
Howard A Fine, M.D.
United States: Federal Government
|National Institutes of Health||Bethesda, Maryland 20892|