Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

815

Participants

Timeline

Start Date

February 23, 2000

Primary Completion Date

October 8, 2012

Study Completion Date

January 31, 2013

Conditions
Iris MelanomaMedium/Large Size Posterior Uveal MelanomaMucosal MelanomaOcular Melanoma With Extraocular ExtensionRecurrent MelanomaRecurrent Uveal MelanomaSmall Size Posterior Uveal MelanomaStage IIA Cutaneous Melanoma AJCC v6 and v7Stage IIA Uveal Melanoma AJCC v7Stage IIB Cutaneous Melanoma AJCC v6 and v7Stage IIB Uveal Melanoma AJCC v7Stage IIC Cutaneous Melanoma AJCC v6 and v7Stage IIIA Cutaneous Melanoma AJCC v7Stage IIIA Uveal Melanoma AJCC v7Stage IIIB Cutaneous Melanoma AJCC v7Stage IIIB Uveal Melanoma AJCC v7Stage IIIC Cutaneous Melanoma AJCC v7Stage IIIC Uveal Melanoma AJCC v7Stage IV Cutaneous Melanoma AJCC v6 and v7Stage IV Uveal Melanoma AJCC v7
Interventions
OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo

Given GM-CSF placebo SC

OTHER

Placebo

Given peptide placebo SC

BIOLOGICAL

Sargramostim

Given SC

BIOLOGICAL

Tyrosinase Peptide

Given SC

Trial Locations (148)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10466

Montefiore Medical Center-Wakefield Campus, The Bronx

10595

New York Medical College, Valhalla

10940

Orange Regional Medical Center, Middletown

11794

Stony Brook University Medical Center, Stony Brook

12801

Glens Falls Hospital, Glens Falls

14623

Interlakes Foundation Inc-Rochester, Rochester

14642

University of Rochester, Rochester

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

17822

Geisinger Medical Center, Danville

18015

Saint Luke's University Hospital-Bethlehem Campus, Bethlehem

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

18840

Guthrie Medical Group PC-Robert Packer Hospital, Sayre

19026

Delaware County Memorial Hospital, Drexel Hill

19047

Saint Mary Medical and Regional Cancer Center, Langhorne

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19301

Paoli Memorial Hospital, Paoli

19464

Pottstown Hospital, Pottstown

21204

Greater Baltimore Medical Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

21401

Anne Arundel Medical Center, Annapolis

25304

West Virginia University Charleston Division, Charleston

27104

Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem

27534

Wayne Memorial Hospital, Goldsboro

27710

Duke University Medical Center, Durham

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28204

Novant Health Presbyterian Medical Center, Charlotte

29425

Medical University of South Carolina, Charleston

30033

Atlanta VA Medical Center, Decatur

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30912

Augusta University Medical Center, Augusta

31201

Medical Center of Central Georgia, Macon

31602

South Georgia Medical Center/Pearlman Cancer Center, Valdosta

32207

Baptist MD Anderson Cancer Center, Jacksonville

32803

AdventHealth Orlando, Orlando

33140

Mount Sinai Medical Center, Miami Beach

33331

Cleveland Clinic-Weston, Weston

33401

Florida Cancer Specialists-West Palm Beach, West Palm Beach

33458

Jupiter Medical Center, Jupiter

33805

Lakeland Regional Health Hollis Cancer Center, Lakeland

33901

Southwest Florida Regional Medical Center, Fort Myers

35233

University of Alabama at Birmingham Cancer Center, Birmingham

36607

Mobile Infirmary Medical Center, Mobile

37232

Vanderbilt University/Ingram Cancer Center, Nashville

39401

Hattiesburg Clinic - Hematology/Oncology Clinic, Hattiesburg

40202

The James Graham Brown Cancer Center at University of Louisville, Louisville

43210

Ohio State University Comprehensive Cancer Center, Columbus

44106

Case Western Reserve University, Cleveland

44109

MetroHealth Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44710

Aultman Health Foundation, Canton

45219

University of Cincinnati/Barrett Cancer Center, Cincinnati

45420

Dayton NCI Community Oncology Research Program, Dayton

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

IU Health Methodist Hospital, Indianapolis

47303

IU Health Ball Memorial Hospital, Muncie

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

49007

West Michigan Cancer Center, Kalamazoo

49503

Cancer Research Consortium of West Michigan NCORP, Grand Rapids

50010

McFarland Clinic PC - Ames, Ames

50309

Iowa Methodist Medical Center, Des Moines

Iowa-Wide Oncology Research Coalition NCORP, Des Moines

Medical Oncology and Hematology Associates-Des Moines, Des Moines

51101

Siouxland Regional Cancer Center, Sioux City

52803

Genesis Medical Center - East Campus, Davenport

53066

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53188

ProHealth Waukesha Memorial Hospital, Waukesha

53212

Aurora Cancer Care-Glendale, Glendale

53792

University of Wisconsin Hospital and Clinics, Madison

54221

Holy Family Memorial Hospital, Manitowoc

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

Marshfield Medical Center-Marshfield, Marshfield

55422

North Memorial Medical Health Center, Robbinsdale

55905

Mayo Clinic, Rochester

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

58501

Mid Dakota Clinic, Bismarck

Sanford Bismarck Medical Center, Bismarck

59101

Saint Vincent Healthcare, Billings

59102

Montana Cancer Consortium NCORP, Billings

60153

Loyola University Medical Center, Maywood

60504

Rush - Copley Medical Center, Aurora

60611

Northwestern University, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61801

Carle Cancer Center, Urbana

62781

Memorial Medical Center, Springfield

63141

Saint Louis-Cape Girardeau CCOP, St Louis

65212

University of Missouri - Ellis Fischel, Columbia

65804

Cancer Research for the Ozarks NCORP, Springfield

66160

University of Kansas Cancer Center, Kansas City

67214

Wichita NCI Community Oncology Research Program, Wichita

68114

Nebraska Methodist Hospital, Omaha

68122

Alegent Health Immanuel Medical Center, Omaha

68124

Alegent Health Bergan Mercy Medical Center, Omaha

68131

Creighton University Medical Center, Omaha

68198

University of Nebraska Medical Center, Omaha

68803

CHI Health Saint Francis, Grand Island

70121

Ochsner Medical Center Jefferson, New Orleans

70809

Ochsner Health Center-Summa, Baton Rouge

72205

University of Arkansas for Medical Sciences, Little Rock

73505

Cancer Centers of Southwest Oklahoma Research, Lawton

74104

Saint John Medical Center, Tulsa

74136

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa

75230

Medical City Dallas Hospital, Dallas

80012

The Medical Center of Aurora, Aurora

80113

Swedish Medical Center, Englewood

80218

SCL Health Saint Joseph Hospital, Denver

80301

Boulder Community Hospital, Boulder

81501

Saint Mary's Hospital and Regional Medical Center, Grand Junction

83712

Saint Luke's Mountain States Tumor Institute, Boise

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

85259

Mayo Clinic in Arizona, Scottsdale

85719

Banner University Medical Center - Tucson, Tucson

87102

University of New Mexico Cancer Center, Albuquerque

89102

University Medical Center of Southern Nevada, Las Vegas

89106

Nevada Cancer Research Foundation CCOP, Las Vegas

91010

City of Hope Comprehensive Cancer Center, Duarte

92093

UC San Diego Moores Cancer Center, La Jolla

92108

Kaiser Permanente-San Diego Mission, San Diego

92134

Naval Medical Center -San Diego, San Diego

92161

Veterans Administration-San Diego Medical Center, San Diego

92868

Saint Joseph Hospital - Orange, Orange

94304

Stanford Cancer Institute Palo Alto, Palo Alto

VA Palo Alto Health Care System, Palo Alto

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97213

Providence Portland Medical Center, Portland

98112

Kaiser Permanente Washington, Seattle

98274

Skagit Valley Hospital, Mount Vernon

06040

Manchester Memorial Hospital, Manchester

32224-9980

Mayo Clinic in Florida, Jacksonville

30905-5650

Eisenhower Army Medical Center, Fort Gordon

04401

Eastern Maine Medical Center, Bangor

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

01301

Franklin Medical Center, Greenfield

01199

Baystate Medical Center, Springfield

03756

Dartmouth Hitchcock Medical Center, Lebanon

07018-1095

Veterans Adminstration New Jersey Health Care System, East Orange

08690

The Cancer Institute of New Jersey Hamilton, Hamilton

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

37614-0054

East Tennessee State University, Johnson City

05405

University of Vermont and State Agricultural College, Burlington

98122-4307

Swedish Medical Center-First Hill, Seattle

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01989572 - Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery | Biotech Hunter | Biotech Hunter