Protocol Number: 08-C-0214

Title:

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

Number:

08-C-0214

Summary:

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 Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large database. Theses classes are based on Karnofsky Performance Status (KPS), age and disease status.

-The RTOG RPA classes do not include neuropsychological function as a measure of outcome.

-There is no consensus of standardization of test selection to measure changes in neuropsychological functioning in this patient population.

-Neuropsychological function has an important effect on quality of life and should be included when determining prognosis and treatment options for patients.

-Neuropsychological functioning is important when determining the effects of treatments and for measuring outcomes in clinical trials

Objectives:

-To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases.

-To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases.

Eligibility:

-Patients age 18 years and older.

-Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.

-The patient must communicate in English in order to complete the neuropsychological evaluations.

Design:

-This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy.

-Patients will undergo a battery of neuropsychological tests prior to radiotherapy (WBRT or WBRT followed by SRS), and then after radiation at one month post-baseline (2 weeks after radiation therapy), then at 2, 4, and 6 months, and then every 3 months for up to 12 months after baseline.

-The test battery will involve approximately 40 minutes of direct cognitive testing and 15 minutes of questionnaires.

There will be three cohorts of 20 patients each for a total of 60 patients. The three cohorts will be made up of differing histologies and will be sorted on the basis of their RTOG RPA Class.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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 14 days of baseline neuropsychological testing.

-Patients must not receive systemic therapy within 14 days prior to baseline neuropsychological testing.

-Patients who have had surgery for their current brain metastasis must wait at least 14 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 leptomeningeal metastases on spinal MRI.

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.

Special Instructions:

Currently Not Provided

Keywords:

Cancer

Radiation

Brain

Neuropsychological Outcome

Metastasis

Recruitment Keyword(s):

None

Condition(s):

Brain Metastasis

Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44. Review.

Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87. Review.

Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. Review.

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