Status:
COMPLETED
Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain Metastasis
Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Background: * There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to...
Detailed Description
Background: * Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year. * The Radiation Therapy Oncology G...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must be 18 years of age or older.
- Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.
- Cohort 1 (N=20): KPS greater than 70; Age less than or equal to 65; controlled primary tumor and no extracranial metastases.
- Cohort 2 (N=20): KPS greater than 70 and at least one of the following: age greater than 65, uncontrolled or synchronous primary disease, or extracranial metastases
- Cohort 3 (N=20): KPS less than 70
- Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient.
- All patients must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are preformed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
- Subjects of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
- EXCLUSION CRITERIA:
- Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions.
- Inability to communicate in the English language.
- Pre- existing or active psychiatric or neurologic impairments, not caused by the brain metastasis, which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
- Prior Therapy
- Patients must not have been treated for a previous brain metastasis.
- Patients must not have had previous cranial radiation.
- Patients must not undergo treatment with an investigational drug for the primary disease within 7 days of baseline neuropsychological testing.
- Patients must not receive systemic therapy within 7 days prior to baseline neuropsychological testing.
- Patients who have had surgery for their current brain metastasis must wait at least 7 days before baseline neuropsychological testing.
- Concurrent Therapy
- Treatment of primary malignancy with systemic therapy (chemotherapy or biologic agents) cannot be delivered concurrently with the treatment of the intracranial disease. However, treatment of the primary site with local therapy, either surgery or radiotherapy, can be performed concurrently with the treatment of the intracranial disease.
- Patients receiving glucocorticoids should be tapered to the lowest possible dose, or stopped altogether, by the treating physician. If glucocorticoid dose is adjusted or given for the first time, the patient must remain on stable dose of glucocorticoids for at least 24 hours prior to initial neurocognitive testing, CT and MR imaging.
- Patients needing emergent radiation therapy for their brain metastases will be excluded.
- Patients must not have evidence of leptomeningeal metastases.
- Patients must not be HIV positive.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations.
- Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
- Clinically significant unrelated systemic illness which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
Exclusion
Key Trial Info
Start Date :
April 17 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01445483
Start Date
April 17 2009
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892