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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-C-0214

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Fetuses;
Pregnant Women;
Adults who are or may become unable to consent;
Neonates

Special Instructions

Currently Not Provided

Keywords

Cancer;
Radiation;
Brain;
Neuropsychological Outcome;
Metastasis

Recruitment Keyword(s)

Cancer;
Brain;
Brain Metastasis;
Radiation

Condition(s)

Brain Metastasis;
Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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 the brain).

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

Objectives:

- To find out if there is a change in patients cognitive (thinking) and daily functioning after standard radiation treatment for brain metastasis that can be measured with tests.

- To see if any changes on these tests are related to patients response to radiation therapy.

Eligibility:

- Patients 18 years of age or older who have cancer that has spread to the brain.

Design:

- Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a week. Some patients may require stereotactic radiosurgery (an additional boost of radiation therapy to specific sites of brain metastasis).

- Patients have the following evaluations before and after treatment to determine changes in cognition and functioning:

- Neuropsychological testing to measure cognitive (thinking) abilities like memory, attention, processing speed, and reading, and fine motor skills.

- Questionnaires to assess quality of life and daily living skills.

- Patients have MRI scans and blood and urine tests.

- At the completion of radiation treatment, patients return to the clinic for follow-up visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination, MRI of the brain, neuropsychological testing and assessments of quality of life and daily living skills.

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Eligibility

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 24 hours 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.


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Citations:

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

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

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

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Contacts:

Principal Investigator

Referral Contact

For more information:

DeeDee K. Smart, M.D.
National Cancer Institute (NCI)
BG 10-CRC RM B2-3500
10 CENTER DR
BETHESDA MD 20814
(240) 760-6212
ds526v@nih.gov

Debbie Nathan, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 2-1730
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6955
dnathan@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01445483

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