Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
Cognitive/Functional Effects, Metastatic Cancer, Neurotoxicity
About this trial
This is an interventional supportive care trial for Cognitive/Functional Effects focused on measuring cognitive/functional effects, neurotoxicity, tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
- If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)
- Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality
- Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI
- Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)
- Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans
PATIENT CHARACTERISTICS:
Inclusion
- Karnofsky performance status 70-100%
- Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 2.5 mg/dL
- Blood urea nitrogen (BUN) < 20 mg/dL
- Mini-mental status exam score ≥ 18
- Negative serum pregnancy test
- Fertile patients must practice adequate contraception
Exclusion
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Pregnant or lactating women
- Prior allergic reaction to memantine hydrochloride
- Current alcohol or drug abuse
- Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
PRIOR CONCURRENT THERAPY:
Inclusion
- At least 14 days but no more than 56 days since prior therapy for brain metastasis, including radiosurgery and surgical resection
- No systemic chemotherapy for 14 days prior, during, or for 14 days after completion of whole-brain radiotherapy (WBRT)
Exclusion
Prior cranial radiotherapy
- Patients may have received up to 3 prior WBRT treatments and still be registered and randomized on the protocol provided WBRT parameters meet protocol requirements
- Chronic short-acting benzodiazepine use
Sites / Locations
- MBCCOP - Gulf Coast
- Providence Cancer Center at Providence Hospital
- Arizona Oncology Services Foundation
- Mayo Clinic Scottsdale
- Arizona Oncology - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Auburn Radiation Oncology
- Providence Saint Joseph Medical Center - Burbank
- Radiation Oncology Centers - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center
- Enloe Cancer Center at Enloe Medical Center
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Comprehensive Cancer Center
- Glendale Adventist Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- USC/Norris Comprehensive Cancer Center and Hospital
- St. Joseph Hospital Regional Cancer Center - Orange
- Radiation Oncology Center - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of California Davis Cancer Center
- Mercy General Hospital
- Stanford Cancer Center
- Emanuel Regional Cancer Services at Emanuel Medical Center
- Solano Radiation Oncology Center
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Rocky Mountain Cancer Centers - Aurora
- Rocky Mountain Cancer Centers - Colorado Springs
- Poudre Valley Radiation Oncology
- Yale Cancer Center
- CCOP - Christiana Care Health Services
- Washington Cancer Institute at Washington Hospital Center
- University of Florida Shands Cancer Center
- Integrated Community Oncology Network
- Baptist Cancer Institute - Jacksonville
- Integrated Community Oncology Network at Southside Cancer Center
- Baptist Medical Center South
- Integrated Community Oncology Network - Orange Park
- Florida Institute of Research, Medicine and Surgery Cancer Center
- Florida Cancer Center - Palatka
- Flagler Cancer Center
- Winship Cancer Institute of Emory University
- John B. Amos Cancer Center
- Veterans Affairs Medical Center - Atlanta (Decatur)
- Northeast Georgia Medical Center
- Northwest Community Hospital
- John H. Stroger, Jr. Hospital of Cook County
- Cancer Institute at St. John's Hospital
- CCOP - Carle Cancer Center
- Saint John's Cancer Center at Saint John's Medical Center
- Bloomington Hospital Regional Cancer Institute
- Radiation Oncology Associates Southwest
- Parkview Regional Cancer Center at Parkview Health
- Center for Cancer Care at Goshen General Hospital
- Indiana University Melvin and Bren Simon Cancer Center
- Methodist Cancer Center at Methodist Hospital
- Central Indiana Cancer Centers - East
- Community Regional Cancer Care at Community Hospital East
- Community Regional Cancer Care at Community Hospital North
- Cancer Center at Ball Memorial Hospital
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas City Cancer Centers - Southwest
- Lucille P. Markey Cancer Center at University of Kentucky
- Norton Suburban Hospital
- Greenebaum Cancer Center at University of Maryland Medical Center
- St. Agnes Hospital Cancer Center
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
- Good Samaritan Hospital of Maryland
- Central Maryland Oncology Center
- Tate Cancer Center at Baltimore Washington Medical Center
- Cancer Institute at St. Joseph Medical Center
- Boston University Cancer Research Center
- Charach Cancer Center at Huron Valley - Sinai Hospital
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Great Lakes Cancer Institute at McLaren Regional Medical Center
- CCOP - Grand Rapids
- St. Mary Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Albert Lea Cancer Center at Albert Lea Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Immanuel St. Joseph's
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- Mayo Clinic Cancer Center
- CentraCare Clinic - River Campus
- CCOP - Metro-Minnesota
- United Hospital
- Ridgeview Medical Center
- Regional Cancer Center at Singing River Hospital
- Kansas City Cancer Centers - South
- Kansas City Cancer Centers - North
- CCOP - St. Louis-Cape Girardeau
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Northern Rockies Radiation Oncology Center
- Billings Clinic - Downtown
- Methodist Estabrook Cancer Center
- Nebraska Medical Center
- CCOP - Nevada Cancer Research Foundation
- Renown Institute for Cancer at Renown Regional Medical Center
- Payson Center for Cancer Care at Concord Hospital
- Elliot Regional Cancer Center at Elliot Hospital
- Ocean Medical Center at Meridian Health
- Cancer Institute of New Jersey at Cooper University Hospital - Camden
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
- Princeton Radiation Oncology Center
- Saint Peter's University Hospital
- University Medical Center at Princeton
- J. Phillip Citta Regional Cancer Center at Community Medical Center
- Cancer Institute of New Jersey at Cooper - Voorhees
- Lovelace Medical Center - Downtown
- Radiation Oncology Associates, PA
- University of New Mexico Cancer Center
- New York Oncology Hematology, PC at Albany Regional Cancer Care
- Veterans Affairs Medical Center - Albany
- New York Methodist Hospital
- Roswell Park Cancer Institute
- Sands Cancer Center
- CCOP - North Shore University Hospital
- Long Island Jewish Medical Center
- Highland Hospital of Rochester
- Lipson Cancer and Blood Center at Rochester General Hospital
- University Radiation Oncology at Parkridge Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Mission Hospitals - Memorial Campus
- New Hanover Radiation Oncology, PA
- Trinity CancerCare Center
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Cleveland Clinic Cancer Center
- Northwest Ohio Oncology Center
- Hillcrest Cancer Center at Hillcrest Hospital
- St. Charles Mercy Hospital
- Cancer Care Center, Incorporated
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Precision Radiotherapy at University Pointe
- Cancer Treatment Center
- Cleveland Clinic - Wooster
- Oklahoma University Cancer Institute
- Willamette Valley Cancer Center - Eugene
- Three Rivers Community Hospital
- Dubs Cancer Center at Rogue Valley Medical Center
- Providence Cancer Center at PMCC
- Rosenfeld Cancer Center at Abington Memorial Hospital
- UPMC Cancer Center at Beaver Medical Center
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- UPMC Cancer Center at Jefferson Regional Medical Center
- Cancer Center at Clarion Hospital
- Geisinger Cancer Institute at Geisinger Health
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Northeast Radiation Oncology Center
- Adams Cancer Center
- UPMC Cancer Center - Arnold Palmer Pavilion
- Cherry Tree Cancer Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- UPMC Cancer Center at the John P. Murtha Pavilion
- UPMC Cancer Center at UPMC McKeesport
- UPMC - Moon
- UPMC Cancer Center - Natrona Heights
- Jameson Memorial Hospital - North Campus
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Albert Einstein Cancer Center
- UPMC - Shadyside
- UPMC Cancer Center at Magee-Womens Hospital
- UPMC Cancer Center at UPMC St. Margaret
- UPMC Cancer Center at UPMC Passavant
- UPMC Cancer Center - Upper St. Clair
- UPMC Cancer Center at UPMC Northwest
- UPMC Cancer Center - Uniontown
- Washington Hospital Cancer Center
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Apple Hill Medical Center
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Rapid City Regional Hospital
- Texas Oncology, PA at Texas Cancer Center - Arlington South
- Texas Oncology, PA at Harris Center HEB
- Medical City Dallas Hospital
- Texas Oncology, PA at Texas Cancer Center Dallas Southwest
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Texas Oncology, PA at Texas Cancer Center - Denton South
- Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
- Longview Cancer Center
- West Texas Cancer Center
- Cancer Care Centers of South Texas - Northeast
- University of Texas Health Science Center at San Antonio
- Texas Oncology, PA at Texas Cancer Center - Sherman
- Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
- Tyler Cancer Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Dixie Regional Medical Center - East Campus
- Utah Cancer Specialists at UCS Cancer Center
- Huntsman Cancer Institute at University of Utah
- Fletcher Allen Health Care - University Health Center Campus
- University of Virginia Cancer Center
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- CCOP - Virginia Mason Research Center
- Cancer Care Northwest - Spokane South
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Schiffler Cancer Center at Wheeling Hospital
- Theda Care Cancer Institute
- St. Vincent Hospital Regional Cancer Center
- Franciscan Skemp Healthcare - La Crosse Campus
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Community Memorial Hospital Cancer Care Center
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
- Medical College of Wisconsin Cancer Center
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- West Allis Memorial Hospital
- Nova Scotia Cancer Centre
- London Regional Cancer Program at London Health Sciences Centre
- Maisonneuve-Rosemont Hospital
- Hopital Notre-Dame du CHUM
- McGill Cancer Centre at McGill University
- Centre Hospitalier Universitaire de Quebec
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
WBRT+Memantine
WBRT+Placebo
Whole brain radiation therapy (WBRT) and memantine
Whole brain radiation therapy (WBRT) and placebo