MedTrace Logo

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

NCT00047879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2011-10-26

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

PEG-interferon alfa-2b

0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection

DRUG

Thalidomide

Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Howard A Fine, M.D. · NCI, NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00047879 on ClinicalTrials.gov