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A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cognitive/Functional Effects, Metastatic Cancer, Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy


OBJECTIVES:

Primary

- Determine whether the addition of memantine hydrochloride to whole-brain radiotherapy
(WBRT) preserves cognitive function, specifically memory, as measured by the Hopkins
Verbal Learning Test for delayed recall (HVLT-delayed recall), over that of placebo and
WBRT in patients with brain metastases at 24 weeks from the start of drug treatment.

Secondary

- Determine whether the addition of memantine hydrochloride preserves cognitive function,
specifically memory, as measured by the HVLT-delayed recall at 8 weeks, 16 weeks, and
12 months from the start of drug treatment.

- Determine whether the addition of memantine hydrochloride increases time to
neurocognitive failure as measured by cognitive decline on a battery of tests including
the HVLT for free recall, delayed recall, and delayed recognition; the Controlled Word
Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical
Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status
Examination (MMSE).

- Evaluate the potential benefit of memantine hydrochloride in change and overall quality
of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
subscale.

- Determine whether the addition of memantine hydrochloride increases progression-free
survival.

- Determine whether the addition of memantine hydrochloride increases overall survival.

- Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria.

- Collect serum, plasma, buffy coat cells, urine, and CSF for future translational
research analyses.

OUTLINE: This is a multicenter study. Patients are stratified according to recursive
partitioning analysis (RPA) prognostic class (class I vs class II with controlled systemic
disease) and prior surgical therapy (none vs radiosurgery or surgical resection). Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks (15
fractions). Patients also receive oral memantine hydrochloride once daily beginning on
day 1 of WBRT and continuing for 24 weeks.

- Arm II: Patients undergo WBRT as in arm I. Patients also receive oral placebo once
daily beginning on day 1 of WBRT and continuing for 24 weeks.

After completion of study treatment, patients are followed at 6 months, every 4 months for 1
year, every 6 months for 2 years, and then annually thereafter.

Inclusion 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Cognitive function, specifically memory, 24 weeks from the start of drug treatment as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-delayed recall)

Safety Issue:

No

Principal Investigator

Paul D. Brown, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000577872

NCT ID:

NCT00566852

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Metastatic Cancer
  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cognitive/functional effects
  • neurotoxicity
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Neurotoxicity Syndromes

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Northwest Community HospitalArlington Heights, Illinois  60005
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
New York Methodist HospitalBrooklyn, New York  11215-3609
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Yale Cancer CenterNew Haven, Connecticut  06520-8028
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Northwest Ohio Oncology CenterMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Cleveland Clinic - WoosterWooster, Ohio  44691
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Washington  98902
Poudre Valley Radiation OncologyFort Collins, Colorado  80528
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
Great Lakes Cancer Institute at McLaren Regional Medical CenterFlint, Michigan  48532
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Treatment CenterWooster, Ohio  44691
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Stanford Cancer CenterStanford, California  94305-5824
John B. Amos Cancer CenterColumbus, Georgia  31904
St. Mary Mercy HospitalLivonia, Michigan  48154
Billings Clinic - DowntownBillings, Montana  59107-7000
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Enloe Cancer Center at Enloe Medical CenterChico, California  95926
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Theda Care Cancer InstituteAppleton, Wisconsin  54911
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Solano Radiation Oncology CenterVacaville, California  95687
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
Tyler Cancer CenterTyler, Texas  75702
Boston University Cancer Research CenterBoston, Massachusetts  02118
Good Samaritan Hospital of MarylandBaltimore, Maryland  21239
Mercy General HospitalSacramento, California  95819
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Trinity CancerCare CenterMinot, North Dakota  58701
Franciscan Skemp Healthcare - La Crosse CampusLa Crosse, Wisconsin  54601
Cancer Care Center, IncorporatedSalem, Ohio  44460
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Ocean Medical Center at Meridian HealthBrick, New Jersey  08724
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Providence Cancer Center at PMCCMedford, Oregon  97504
Albert Lea Cancer Center at Albert Lea Medical CenterAlbert Lea, Minnesota  56007
Central Maryland Oncology CenterColumbia, Maryland  21044
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Immanuel St. Joseph'sMankato, Minnesota  56002
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
West Texas Cancer CenterOdessa, Texas  79761
UPMC Cancer Center at Beaver Medical CenterBeaver, Pennsylvania  15009
UPMC Cancer Center at Jefferson Regional Medical CenterClairton, Pennsylvania  15025
UPMC Cancer Center - Arnold Palmer PavilionGreensburg, Pennsylvania  15601
UPMC Cancer Center at the John P. Murtha PavilionJohnstown, Pennsylvania  15901
UPMC - MoonMoon Township, Pennsylvania  15108
UPMC Cancer Center - Natrona HeightsNatrona Heights, Pennsylvania  15065
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
UPMC - ShadysidePittsburgh, Pennsylvania  15213-2582
UPMC Cancer Center at UPMC St. MargaretPittsburgh, Pennsylvania  15215
UPMC Cancer Center at UPMC PassavantPittsburgh, Pennsylvania  15237
UPMC Cancer Center at UPMC NorthwestSeneca, Pennsylvania  16346
Washington Hospital Cancer CenterWashington, Pennsylvania  15301
University Medical Center at PrincetonPrinceton, New Jersey  08540
Radiation Oncology Associates, PAAlbuquerque, New Mexico  87109
Cancer Institute at St. Joseph Medical CenterTowson, Maryland  21204
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208
Glendale Adventist Medical CenterGlendale, California  91206
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Sands Cancer CenterCanandiaqua, New York  14424
University Radiation Oncology at Parkridge HospitalRochester, New York  14626
Community Regional Cancer Care at Community Hospital NorthIndianapolis, Indiana  46256
Community Regional Cancer Care at Community Hospital EastIndianapolis, Indiana  46219
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Longview Cancer CenterLongview, Texas  75601
Rocky Mountain Cancer Centers - Colorado SpringsColorado Springs, Colorado  80933-1181
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Radiation Oncology Associates SouthwestFort Wayne, Indiana  46804
Central Indiana Cancer Centers - EastIndianapolis, Indiana  46219
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Payson Center for Cancer Care at Concord HospitalConcord, New Hampshire  03301
Trinitas Comprehensive Cancer Center at Trinitas HospitalElizabeth, New Jersey  07207
Willamette Valley Cancer Center - EugeneEugene, Oregon  97401
Texas Oncology, PA at Harris Center HEBBedford, Texas  76022
Texas Oncology, PA at Texas Cancer Center - Denton SouthDenton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Cancer Care Centers of South Texas - NortheastSan Antonio, Texas  78217
Texas Oncology, PA at Texas Cancer Center - ShermanSherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Bloomington Hospital Regional Cancer InstituteBloomington, Indiana  47403
Nebraska Medical CenterOmaha, Nebraska  68198
Emanuel Regional Cancer Services at Emanuel Medical CenterTurlock, California  95382
Princeton Radiation Oncology CenterJamesburg, New Jersey  08831
Arizona Oncology - TucsonTucson, Arizona  85704
Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
Norton Suburban HospitalLouisville, Kentucky  40207
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
New Hanover Radiation Oncology, PAWilmington, North Carolina  28401
Cancer Center at Clarion HospitalClarion, Pennsylvania  16214
UPMC Cancer Center at UPMC McKeesportMcKeesport, Pennsylvania  15132
UPMC Cancer Center - Upper St. ClairPittsburgh, Pennsylvania  15243
UPMC Cancer Center - UniontownUniontown, Pennsylvania  15401
Texas Oncology, PA at Texas Cancer Center Dallas SouthwestDallas, Texas  75237
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
Tate Cancer Center at Baltimore Washington Medical CenterGlen Burnie, Maryland  21061
Texas Oncology, PA at Texas Cancer Center - Arlington SouthArlington, Texas  76014
Florida Institute of Research, Medicine and Surgery Cancer CenterOrlando, Florida  32806
Charach Cancer Center at Huron Valley - Sinai HospitalCommerce, Michigan  48382