Bethesda, Maryland 20892

  • Unspecified Adult Solid Tumor, Protocol Specific

Purpose:

RATIONALE: Learning about the neuropsychological function in patients undergoing radiation therapy for brain metastases may help doctors learn more about the long-term effects of radiation therapy and help plan the best treatment. PURPOSE: This clinical trial is studying neuropsychological measures in patients undergoing radiation therapy for brain metastases.


Study summary:

OBJECTIVES: Primary - To identify neuropsychological test scores that detect significant change in neuropsychological functioning in patients undergoing radiotherapy for brain metastases. - To examine the relationship between neuropsychological function and survival of these patients. Secondary - To further examine whether other measures from the following battery of tests detect significant change in neuropsychological function or predict prognosis in these patients: North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal Learning Test (HVLT), WAIS-III Digit Span Subtest, WAIS-III Symbol Search Subtest, Ruff 2 and 7 Selective Attention Test, Trail Making Test Part A and B (TMT), Controlled Oral Word Association Test (COWAT), Grooved Pegboard, Barthel Index, and the Functional Assessment of Cancer Therapy-Brain (FACT-Br). - To examine the relationship between the RTOG recursive partitioning analysis (RPA) classification for brain metastasis survival and baseline neuropsychological functioning in these patients. - To examine the strengths and weaknesses in neuropsychological functioning of these patients after radiotherapy. - To explore the neuropsychological functioning of patients treated with different therapies (e.g., chemotherapy, corticosteroids, or complete surgical resection). - To investigate the relationship between neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence in these patients. - To investigate the role of biomarkers, including NSE, S100B, MMPs, and VEGF, as potential markers of brain injury and disease progression using serum, plasma, and urine samples from these patients. - To gather baseline neuropsychological data for use as a reference in the development of new clinical trials involving this patient population in the Radiation Oncology Branch (ROB). OUTLINE: Patients are stratified according to RTOG recursive partitioning analysis (RPA) classification. Patients undergo whole brain radiotherapy once daily 5 days a week for 2 weeks (10 fractions). Some patients may then undergo stereotactic radiosurgery boost. Patients undergo neuropsychological testing (involving 40 minutes of direct cognitive testing and 15 minutes of questionnaires) at baseline and at 1, 3, 6, 9, and 12 months. Blood and urine samples are collected periodically for laboratory biomarker studies. Blood samples are analyzed for NSE and S100B by ELISA. Urine samples are analyzed for MMP by ELISA.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed primary malignancy - At least one intraparenchymal brain metastasis as identified on brain MRI with IV contrast - Meets one of the following criteria according to the RTOG recursive partitioning analysis (RPA) classification: - Class I - Age 65 and under - Controlled primary tumor - No extracranial metastases - Karnofsky performance status (KPS) 70-100% - Class II - KPS 70-100% AND meets at least 1 of the following criteria: - Uncontrolled or synchronous primary disease - Extracranial metastases - Over 65 years of age - Class III - KPS less than 70% - No leptomeningeal metastases PATIENT CHARACTERISTICS: - See Disease Characteristics - Able to communicate in English - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No impaired cognition that would preclude giving informed consent - No pre-existing or active psychiatric or neurologic impairment (not caused by the brain metastasis), other medical condition, or clinically significant unrelated systemic illness, that in the opinion of the investigator, would preclude study participation - No HIV positivity PRIOR CONCURRENT THERAPY: - No treatment for prior brain metastasis - No prior cranial radiotherapy - More than 14 days since prior investigational drugs for the primary malignancy - More than 7 days since prior and no concurrent systemic therapy (e.g., chemotherapy, immunotherapy, or biological therapy) - At least 14 days since prior surgery for the current brain metastases - No concurrent neurosurgery - No concurrent emergent radiotherapy for brain metastases - No concurrent investigational drugs - Concurrent local therapy (e.g., surgery or radiotherapy) for the primary malignancy allowed


NCT ID:

NCT00769444


Primary Contact:

Principal Investigator
Kevin Camphausen, MD
NCI - Radiation Oncology Branch; ROB


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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