At a glance
ClinicalIndex Comparison Record- ✓Histologically proven supratentorial malignant primary gliomas: GBM, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma NOS
- ✓Evaluable or measurable disease with unequivocal evidence of tumor recurrence or progression on MRI or CT
- ✓Prior failed radiation therapy with interval ≥4 weeks from completion to study entry
- ✓For prior brachytherapy/stereotactic radiosurgery: confirmation of progressive disease (not radiation necrosis) by PET, Thallium scanning, MR spectroscopy, or surgical documentation
- ✕Serious active infection
- ✕Disease that will obscure toxicity or dangerously alter drug metabolism
- ✕Serious intercurrent medical illness or significant illness that cannot be adequately controlled
- ✕Concurrent chemotherapy, immunotherapy, or radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas
In Brief
A Phase 2 clinical trial evaluating PEG-interferon alfa-2b and Thalidomide for Glioma. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection
Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.