Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron)
alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas
are nourished by blood delivered through blood vessels whose formation is stimulated by
substances produced by the tumor itself. Stopping the growth of new vessels can slow or
prevent tumor growth. The Food and Drug Administration has approved various interferons for
treating several diseases, including melanoma and some leukemias. These drugs block new
vessel growth in patients with recurrent tumors, but in high doses they produce serious side
effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high
doses given several times a week. Thalidomide, currently approved to treat leprosy, also
blocks development of new blood vessel formation. In a recent study of thalidomide given to
36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least
2 months, and at least 3 had responses to treatment lasting 6 to 14 months.
Patients 18 years of age and older with a primary glioma whose tumor has recurred or is
growing following standard treatment and does not respond to radiation therapy may be
eligible for this study. Candidates will be screened with a physical examination, blood and
urine tests (including a pregnancy test for women of childbearing potential), and magnetic
resonance imaging (MRI) or computed tomography (CT) of the head.
Patients will continue treatment cycles as long as the drug is tolerated without serious side
effects and the tumor is not growing. While on the study, patients will undergo various tests
and procedures as follows:
Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to
assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio
waves to show structural and chemical changes in tissues. During the scan, the patient lies
on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff
member through an intercom system at all times during the procedure.