A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases

Inclusion Criteria

-INCLUSION CRITERIA:

1. Patients must be 18 years of age or older.

2. 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

3. 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.

4. 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).

5. 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:

1. Cognitively impaired patients who cannot give informed consent, including patients
assigned a power of attorney for medical decisions.

2. Inability to communicate in the English language.

3. 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.

4. 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.

5. 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 3 days prior to initial neurocognitive testing,
CT and MR imaging.

6. Patients needing emergent radiation therapy for their brain metastases will be
excluded

7. Patients must not have evidence of leptomeningeal metastases.

8. Patients must not be HIV positive.

9. Other medical conditions deemed by the PI or associates to make the patient
ineligible for protocol investigations.

10. Pregnant or breast-feeding females are excluded because of the potential mutagenic
effects on a developing fetus or newborn.

11. 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.