Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas

Background:

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 non-overlapping toxicities.

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.

Objectives:

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.

Eligibility:

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.

Design:

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 disease response.