Protocol Number: 02-C-0145

Title:

A Phase I Trial of a Thalidomide Analog, CC-5013, for the Treatment of Patients with Recurrent High-Grade Gliomas

Number:

02-C-0145

Summary:

This study will determine the highest dose of the experimental drug CC-5013 that can safely be given to 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. CC-5013 is closely related chemically to thalidomide, a drug that can block development of new blood vessel formation. In two studies of patients with brain tumors, thalidomide stopped the growth of gliomas in about one half the patients. However, in most patients the effect only lasted for several months. CC-5013 is much more potent than thalidomide, and may, therefore, be more effective in controlling tumor growth. This study will examine the drug's safety and optimum dosage level as a first step in evaluating its usefulness in treating gliomas.

Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a medical history, 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.

Participants will take CC-5013 capsules once a day for 3 weeks, followed by 1 week off medication. To find the highest tolerable dose, the first group of three patients in the study will start at a low dose, and the dose will be increased gradually in succeeding groups of three patients until side effects become unacceptable. All subsequent patients will then receive the next lower dose, which is the maximum tolerated, or optimum, dose. Patients will continue treatment for up to 12 cycles (about 1 year) as long as the drug is tolerated without serious side effects and the tumor is not growing. After that, the decision to continue or stop therapy will be reviewed. Patients whose tumor grows significantly or who develop unacceptable side effects will be taken of the study. While on the study, patients will undergo various tests and procedures as follows:

- Physical and neurologic examinations every 2 weeks for the first 4-week cycle and every 4 weeks after that

- MRI or CT brain scan every 4 weeks. 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 2 weeks for the first 2 cycles and then every 4 weeks

- Blood drawing immediately before and then 1/2, 1, 2, 4, 6, 8, 24, and 48 hours after the first drug dose on days 1 and 21 to measure CC-5013 blood levels.

- Blood tests every 4 weeks to detect substances that stimulate new blood vessel growth or to determine blood levels of CC-5013

Patients may also be asked to undergo magnetic resonance with spectroscopy (MRS) or PET scanning to help distinguish live tumor from dying tumor. 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: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

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

Disease Category:

PROTICD

Keywords:

Brain Tumor

Toxicity

Pharmacokinetics

Antiangiogenesis

Brain Scan

Recruitment Keywords:

Brain Tumor

Glioma

Gliomas

Conditions:

Glioma

Investigational Drug(s):

CC-5013

Investigational Device(s):

None

Contacts:

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.

Citations:

Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, CareyJ, Baty B, Kivlin J, et al Gene for von Recklinghausen neurofibromatosis is in the pericentromeric regionof chromosome 17Science 1987 May 29;236(4805):1100-2PMID: 3107130

Bigner SH, Bjerkvig R, Laerum OD DNA content and chromosomal composition of malignant human gliomasNeurol Clin 1985 Nov;3(4):769-84 ReviewPMID: 3001489

Moss AR Occupational exposure and brain tumorsJ Toxicol Environ Health 1985;16(5):703-11PMID: 4093991

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