Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
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
8 other identifiers
interventional
815
1 country
148
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2000
Longer than P75 for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedJuly 7, 2020
June 1, 2020
12.6 years
November 18, 2013
July 22, 2014
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival is defined as time from randomization to death from any cause.
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Recurrence Free Survival
Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Secondary Outcomes (4)
Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15
Recurrence Free Survival in HLA-A2 Positive Patients
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
5-year Overall Survival Rate
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
5-year Recurrence Free Survival Rate
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Study Arms (6)
Arm I (sargramostim, peptide vaccine)
EXPERIMENTALPatients receive sargramostim SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Arm II (sargramostim placebo, peptide vaccine)
EXPERIMENTALPatients receive sargramostim placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Arm III (sargramostim, peptide placebo)
EXPERIMENTALPatients receive sargramostim SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Arm IV (placebo, peptide placebo)
PLACEBO COMPARATORPatients receive placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).
Arm V (sargramostim)
EXPERIMENTALPatients receive sargramostim SC on days 1-14.
Arm VI (sargramostim placebo)
PLACEBO COMPARATORPatients receive sargramostim placebo SC on days 1-14.
Interventions
Correlative studies
Given GM-CSF placebo SC
Given SC
Given SC
Eligibility Criteria
You may qualify if:
- Patients must have HLA-A2 status known prior to randomization; typing may be obtained through a local laboratory facility or through a reference lab utilized by the initiating institution; if typing is not available through these means, it may be obtained from the University of Pittsburgh
- All patients must have disease completely resected with one of the following in order to be eligible:
- Completely resected disease
- Any locoregional recurrence after prior adjuvant interferon or failure on S008
- Any local recurrence of disease after adequate surgical excision of the original primary
- Mucosal melanoma
- Stage IV melanoma (cutaneous, ocular, mucosal, or unknown primary)
- The following groups of patients may be entered onto this trial only if they are ineligible for S0008 or are, in the opinion of the managing physician, medically unfit to receive standard high-dose interferon:
- Any clinically evident satellite or in-transit disease
- Stage II disease with gross extracapsular extension
- Recurrence in a previously resected nodal basin
- Four or more involved lymph nodes or matted lymph nodes
- Ulcerated primary melanoma and any involved lymph nodes
- NOTE: Patients who are eligible for S0008 will be strongly encouraged to participate in that study in preference to this one
- Patients must have been surgically rendered free of disease with negative margins on resected specimens; patients rendered free of disease by non-surgical means are not eligible
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (148)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Naval Medical Center -San Diego
San Diego, California, 92134, United States
Veterans Administration-San Diego Medical Center
San Diego, California, 92161, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Manchester Memorial Hospital
Manchester, Connecticut, 06040, United States
Southwest Florida Regional Medical Center
Fort Myers, Florida, 33901, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Florida Cancer Specialists-West Palm Beach
West Palm Beach, Florida, 33401, United States
Cleveland Clinic-Weston
Weston, Florida, 33331, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, 31602, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Franklin Medical Center
Greenfield, Massachusetts, 01301, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Hattiesburg Clinic - Hematology/Oncology Clinic
Hattiesburg, Mississippi, 39401, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Orange Regional Medical Center
Middletown, New York, 10940, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, 10466, United States
New York Medical College
Valhalla, New York, 10595, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, 27104, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
Saint John Medical Center
Tulsa, Oklahoma, 74104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Pottstown Hospital
Pottstown, Pennsylvania, 19464, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
East Tennessee State University
Johnson City, Tennessee, 37614-0054, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Aurora Cancer Care-Glendale
Glendale, Wisconsin, 53212, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
Lawson DH, Lee S, Zhao F, Tarhini AA, Margolin KA, Ernstoff MS, Atkins MB, Cohen GI, Whiteside TL, Butterfield LH, Kirkwood JM. Randomized, Placebo-Controlled, Phase III Trial of Yeast-Derived Granulocyte-Macrophage Colony-Stimulating Factor (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: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E4697). J Clin Oncol. 2015 Dec 1;33(34):4066-76. doi: 10.1200/JCO.2015.62.0500. Epub 2015 Sep 8.
PMID: 26351350DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
David H Lawson
Eastern Cooperative Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 21, 2013
Study Start
February 23, 2000
Primary Completion
October 8, 2012
Study Completion
January 31, 2013
Last Updated
July 7, 2020
Results First Posted
August 12, 2014
Record last verified: 2020-06