ClinicalTrials.gov record
Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
ClinicalTrials.gov ID: NCT01989572
Public ClinicalTrials.gov record NCT01989572. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized phase III trial studies sargramostim or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.
Study identification
- NCT ID
- NCT01989572
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 815 participants
Conditions and interventions
Conditions
- Iris Melanoma
- Medium/Large Size Posterior Uveal Melanoma
- Mucosal Melanoma
- Ocular Melanoma With Extraocular Extension
- Recurrent Melanoma
- Recurrent Uveal Melanoma
- Small Size Posterior Uveal Melanoma
- Stage IIA Cutaneous Melanoma AJCC v6 and v7
- Stage IIA Uveal Melanoma AJCC v7
- Stage IIB Cutaneous Melanoma AJCC v6 and v7
- Stage IIB Uveal Melanoma AJCC v7
- Stage IIC Cutaneous Melanoma AJCC v6 and v7
- Stage IIIA Cutaneous Melanoma AJCC v7
- Stage IIIA Uveal Melanoma AJCC v7
- Stage IIIB Cutaneous Melanoma AJCC v7
- Stage IIIB Uveal Melanoma AJCC v7
- Stage IIIC Cutaneous Melanoma AJCC v7
- Stage IIIC Uveal Melanoma AJCC v7
- Stage IV Cutaneous Melanoma AJCC v6 and v7
- Stage IV Uveal Melanoma AJCC v7
Interventions
- Laboratory Biomarker Analysis Other
- Placebo Other
- Sargramostim Biological
- Tyrosinase Peptide Biological
Other · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 22, 2000
- Primary completion
- Oct 7, 2012
- Completion
- Jan 30, 2013
- Last update posted
- Jun 23, 2026
2000 – 2013
United States locations
- U.S. sites
- 148
- U.S. states
- 44
- U.S. cities
- 120
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Mobile Infirmary Medical Center | Mobile | Alabama | 36607 | — |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | 94704 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Saint Joseph Hospital - Orange | Orange | California | 92868 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Kaiser Permanente-San Diego Mission | San Diego | California | 92108 | — |
| Naval Medical Center -San Diego | San Diego | California | 92134 | — |
| Veterans Administration-San Diego Medical Center | San Diego | California | 92161 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| SCL Health Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | — |
| Manchester Memorial Hospital | Manchester | Connecticut | 06040 | — |
| Southwest Florida Regional Medical Center | Fort Myers | Florida | 33901 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Jupiter Medical Center | Jupiter | Florida | 33458 | — |
| Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | 33805 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Florida Cancer Specialists-West Palm Beach | West Palm Beach | Florida | 33401 | — |
| Cleveland Clinic-Weston | Weston | Florida | 33331 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | — |
| Eisenhower Army Medical Center | Fort Gordon | Georgia | 30905-5650 | — |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | — |
| South Georgia Medical Center/Pearlman Cancer Center | Valdosta | Georgia | 31602 | — |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Memorial Medical Center | Springfield | Illinois | 62781 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| IU Health Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| McFarland Clinic PC - Ames | Ames | Iowa | 50010 | — |
| Genesis Medical Center - East Campus | Davenport | Iowa | 52803 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | — |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| Wichita NCI Community Oncology Research Program | Wichita | Kansas | 67214 | — |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | — |
| Ochsner Health Center-Summa | Baton Rouge | Louisiana | 70809 | — |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Franklin Medical Center | Greenfield | Massachusetts | 01301 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | 49503 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | — |
| North Memorial Medical Health Center | Robbinsdale | Minnesota | 55422 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Hattiesburg Clinic - Hematology/Oncology Clinic | Hattiesburg | Mississippi | 39401 | — |
| University of Missouri - Ellis Fischel | Columbia | Missouri | 65212 | — |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | — |
| Saint Louis-Cape Girardeau CCOP | St Louis | Missouri | 63141 | — |
| Saint Vincent Healthcare | Billings | Montana | 59101 | — |
| Montana Cancer Consortium NCORP | Billings | Montana | 59102 | — |
| CHI Health Saint Francis | Grand Island | Nebraska | 68803 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Alegent Health Immanuel Medical Center | Omaha | Nebraska | 68122 | — |
| Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | — |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey | 07018-1095 | — |
| The Cancer Institute of New Jersey Hamilton | Hamilton | New Jersey | 08690 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | — |
| Glens Falls Hospital | Glens Falls | New York | 12801 | — |
| Orange Regional Medical Center | Middletown | New York | 10940 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Interlakes Foundation Inc-Rochester | Rochester | New York | 14623 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Montefiore Medical Center-Wakefield Campus | The Bronx | New York | 10466 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | — |
| Southeast Clinical Oncology Research (SCOR) Consortium NCORP | Winston-Salem | North Carolina | 27104 | — |
| Mid Dakota Clinic | Bismarck | North Dakota | 58501 | — |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | — |
| Aultman Health Foundation | Canton | Ohio | 44710 | — |
| University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio | 45219 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Dayton NCI Community Oncology Research Program | Dayton | Ohio | 45420 | — |
| Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | 73505 | — |
| Saint John Medical Center | Tulsa | Oklahoma | 74104 | — |
| Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma | 74136 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | — |
| Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | 18015 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | — |
| Saint Mary Medical and Regional Cancer Center | Langhorne | Pennsylvania | 19047 | — |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | — |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | — |
| Pottstown Hospital | Pottstown | Pennsylvania | 19464 | — |
| Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| East Tennessee State University | Johnson City | Tennessee | 37614-0054 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Skagit Valley Hospital | Mount Vernon | Washington | 98274 | — |
| Kaiser Permanente Washington | Seattle | Washington | 98112 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| Aurora Cancer Care-Glendale | Glendale | Wisconsin | 53212 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Holy Family Memorial Hospital | Manitowoc | Wisconsin | 54221 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | — |
| ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01989572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01989572 live on ClinicalTrials.gov.