Protocol Number: 01-C-0070

Title:

Evaluation of the Natural History of Patients with Tumors of the Central Nervous System

Number:

01-C-0070

Summary:

This study offers evaluation of patients with brain and spinal cord tumors. Its purpose is threefold: 1) to allow physicians in NIH's Neuro-Oncology Branch to increase their knowledge of the course of central nervous system tumors and identify areas that need further research; 2) to inform participants of new studies at the National Cancer Institute and other centers as they are developed; and 3) to provide patients consultation on possible treatment options.

Children (at least 1 year old) and adults with primary malignant brain and spinal cord tumors may be eligible for this study. Participants will have a medical history, physical and neurological examinations and routine blood tests. They may also undergo one or more of the following procedures:

-Magnetic resonance imaging (MRI) - MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show detailed changes in brain structure and chemistry. For the procedure, the patient lies on a table in a narrow cylinder containing a magnetic field. A contrast material called gadolinium may be used (injected into a vein) to enhance the images. The procedure takes about an hour, and the patient can speak with a staff member via an intercom system at all times.

-Computed axial tomography (CAT or CT) - CT is a specialized form of X-ray imaging that produces 3-dimensional images of the brain in sections. The scanner is a ring device that surrounds the patient and contains a moveable X-ray source. The scan takes about 30 minutes and may be done with or without the use of a contrast dye.

-Positron emission tomography (PET) - PET is a diagnostic test that is based on differences in how cells take up and use glucose (sugar), one of the body's main fuels. The patient is given an injection of radioactive glucose. A special camera surrounding the patient detects the radiation emitted by the radioactive material and produces images that show how much glucose is being used by various tissues. Fast-growing cells, such as tumors, take up and use more glucose than normal cells do, and therefore, the scan might indicate the overall activity or aggressiveness of the tumor. The procedure takes about an hour.

When all the tests are completed, the physician will discuss the results and potential treatment options with the patient. Follow-up will vary according to the individual. Some patients may end the study with just one visit to NIH, while others may be followed at NIH regularly, in conjunction with their local physicians. Patients with aggressive tumors may be seen every 3 or 4 months, while those with less active tumors may be seen every 6 to 12 months. Permission may be requested for telephone follow-up (with the patient or physician) of patients not seen regularly at NIH.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

All patients greater than or equal to 12 months of age with tumors of the CNS of interest to the NOB, who are not immediately eligible for another ongoing NOB protocol, but who may be candidates at some point in the future.

Patients with tumors of the CNS that are of particular interest to members of the NOB because they pose important clinical and/or scientific questions and/or shed light on important aspects of the disease.

Patients with tumors of the CNS who offer an important educational benefit to neuro-oncology trainees and staff.

Ability for adult patients or individuals granted Durable Power of Attorney (DPA) to give informed consent. Availability of a parent or legal guardian to give informed consent for children.

EXCLUSION CRITERIA:

Patients less than 12 months of age.

Patients who are eligible for other NOB protocols.

Special Instructions: Currently Not Provided

Keywords:

Glioma

Medulloblastoma

Astrocytoma

Glioblastoma

Oligodendriglioma

Recruitment Keywords:

CNS Tumor

Glioma

Medulloblastoma

Astrocytoma

Glioblastoma

Conditions:

Astrocytoma

Central Nervous System Tumor

Glioblastoma

Glioma

Medulloblastoma

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations: Not Provided

• 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 of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004