View Clinical Trial (Medical Research Study)
Evaluation of the Natural History of Patients With Tumors of the Central Nervous System
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Astrocytoma - Central Nervous System Tumor - Glioblastoma - Glioma - Medulloblastoma |
| Purpose: |
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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.
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| Study Summary: |
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Background:
This protocol is designed to evaluate patients with tumors of the central nervous system
(CNS) who appear to be probable candidates for future protocol entry or have disease
manifestations that are of unique scientific interest, importance, and/or educational value.
Objective:
To evaluate patients with tumors of the central nervous system (CNS) who are probable future
candidates for NCI Phase I and II protocols.
To follow patients with tumors of the CNS that are representative of important scientific
and/or clinical principles.
To allow a steady flow of patients with tumors of the CNS at the NIH for the purpose of
educating nurses, medical students, residents, clinical fellows, and physicians in the
management and care of this specialized subgroup of cancer patients.
Eligibility:
All patients greater than or equal to 12 months of age with tumors of the CNS of interest to
the NOB, who may be candidates for another NOB trial 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 of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent document. Availability of a parent or legal
guardian to give informed consent for children.
Design:
All patients will undergo an initial evaluation at the Clinical Center by a member of the
NOB where past medical and oncologic histories will be obtained as well as relevant data
such as neuroimaging and pathology review. A total of 3,000 patients will be accrued to this
study.
Patients may be seen at the NIH Clinical Center at varying intervals depending on the
clinical situation but data related to the natural history of their disease course and
outcome will be collected at least every six months.
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| Criteria: |
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- INCLUSION CRITERIA:
All patients greater than or equal to 12 months of age with tumors of the CNS of interest
to the NOB, who may be candidates for another NOB trial 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 of subject or Legally Authorized Representative (LAR) to understand and the
willingness to sign a written informed consent document. Availability of a parent or
legal guardian to give informed consent for children.
EXCLUSION CRITERIA:
Patients less than 12 months of age.
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| NCT ID: |
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NCT00009035 |
| Primary Contact: |
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Principal Investigator
Teri N Kreisl, M.D.
National Cancer Institute (NCI)
Amanda W Wiggins
Phone: Not Listed
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| Backup Contact: |
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Email: kreislt@mail.nih.gov
Teri N Kreisl, M.D.
Phone: (301) 402-3423
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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