Protocol Number: 03-C-0002

Title:

A Phase II Study of Peginterferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults with Recurrent High-Grade Gliomas

Number:

03-C-0002

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 tomograpy (CT) of the head.

Participants will be randomly assigned to take PEG-Intron alone or PEG-Intron plus thalidomide. Both groups will receive PEG-Intron injections under the skin once a week for each 6-week treatment cycle. Patients in the thalidomide group will also take thalidomide daily by mouth for each 6-week cycle.

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. CT produces images of the brain in small sections. It can be done from different angles to show a three dimensional picture.

-Routine blood tests every 3 weeks and an additional blood test every 6 weeks

-Urine sample every 6 weeks

-Pregnancy test for women of childbearing potential every week for the first 4 weeks and then every 2 or 4 weeks, depending on menstrual regularity

Patients may also be asked to undergo magnetic resonance with spectroscopy (MRS) or PET scanning to help distinguish living tumors from dying tumors. The experience of having MRS is identical to that of the standard MRI and will be done at the same time as the MRI. PET shows cellular activity in the brain. For this test, a sugar solution with a radioactive particle attached is injected through a vein. The radioactive substance allows the fluid to be seen with a special gamma camera. The sugar is fuel for cells and is taken up by the most active cells. Since cancer cells are very active, tracing the sugar uptake allows detection of tumor.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Brain Tumors

Experimental

Toxicities

Efficacy

Progression-Free

Recruitment Keyword(s):

Brain Tumor

Glioma

Condition(s):

Glioma

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Peg-Intron

Drug: Thalidomide

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Dinapoli RP, Brown LD, Arusell RM, Earle JD, O'Fallon JR, Buckner JC, Scheithauer BW, Krook JE, Tschetter LK, Maier JA, et al. Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma. J Clin Oncol. 1993 Jul;11(7):1316-21.

Takamiya Y, Friedlander RM, Brem H, Malick A, Martuza RL. Inhibition of angiogenesis and growth of human nerve-sheath tumors by AGM-1470. J Neurosurg. 1993 Mar;78(3):470-6.

Fine HA, Figg WD, Jaeckle K, Wen PY, Kyritsis AP, Loeffler JS, Levin VA, Black PM, Kaplan R, Pluda JM, Yung WK. Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. J Clin Oncol. 2000 Feb;18(4):708-15.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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