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NCT01989572

PHASE3

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

815

Start Date

2000-02-23

Completion Date

2013-01-31

Last Updated

2026-06-24

Healthy Volunteers

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

Inclusion Criteria: * 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 * Patients must be randomized within 112 days (16 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, all required surgeries must be accomplished within this 16 week time period * Patients must not have received any adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial; one systemic treatment after a prior surgery is allowed, and must have been completed \>= 8 weeks prior to randomization; (when chemotherapy and biotherapy are given together as one planned treatment \[biochemotherapy\], this counts as one regimen); NOTE: Previous radiation therapy, including after the resection, is allowed as long as 30 days elapse between the radiation and initiation of therapy * Prior treatment with GM-CSF or any peptides used in this protocol, is not allowed * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients must not have an active infection requiring treatment with parenteral antibiotics * Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that may interfere with compliance on any of the E4697 treatment regimens * Patients must not have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol * Patients must be able to self-administer or arrange for administration of subcutaneous injections * Patients who have other current malignancies are not eligible * Patients with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ are eligible; patients who meet this criteria must be disease-free at time of randomization * Patients with prior history of basal or squamous skin cancer are eligible; patients who meet this criteria must be disease-free at time of randomization * Patients who have had multiple primary melanomas are eligible * Patients with other malignancies are eligible if they have been continuously disease free for \> 5 years prior to the time of randomization * Patients must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids, including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or any steroid containing inhalers; replacement doses of steroids for patients with adrenal insufficiency are allowed; patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization are eligible if, in the judgment of the treating physician, the patient is not likely to require these classes of drugs during the study * Women of childbearing potential must not be pregnant (negative beta human chorionic gonadotropin \[bHCG\] within 2 weeks prior to randomization) or breast-feeding * Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 18 months after completing or discontinuing treatment * All patients must have brain computed tomography (CT) or magnetic resonance imaging (MRI), chest CT or chest x-ray (CXR), and abdominal (liver) CT or MRI within 4 weeks prior to randomization; positron emission tomography (PET) scans are also acceptable in place of CT, CXR and/or abdominal MRI if obtained within 4 weeks prior to randomization; patients with lesions on the lower extremity must also have pelvic imaging within this time period; this is also strongly recommended for patients with lesions on the lower trunk; PET scans are acceptable * Patients with resection of visceral disease must have imaging of the affected area/organ documenting disease-free status within 2 weeks prior to randomization * White blood cells (WBC) \>= 3,000/mm? * Platelet count \>= 100,000/mm? * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x institutional upper limit (IUL) of normal * Bilirubin =\< 2 x IUL of normal * Serum creatinine =\< 1.8 mg/dl * Alkaline phosphatase and lactate dehydrogenase (LDH) must be performed within 4 weeks prior to randomization; LDH must be normal; patients with abnormal alkaline phosphatase which is =\< 1.25 times the institutional upper limit of normal who have a negative CT or MRI of the liver and negative bone scan or a negative PET scan are eligible * Patients with bone pain must have a bone scan within 4 weeks prior to randomization to document the absence of tumor

Locations (148)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Naval Medical Center -San Diego

San Diego, California, United States

Veterans Administration-San Diego Medical Center

San Diego, California, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

SCL Health Saint Joseph Hospital

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Manchester Memorial Hospital

Manchester, Connecticut, United States

Southwest Florida Regional Medical Center

Fort Myers, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Florida Cancer Specialists-West Palm Beach

West Palm Beach, Florida, United States

Cleveland Clinic-Weston

Weston, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

South Georgia Medical Center/Pearlman Cancer Center

Valdosta, Georgia, United States

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

Rush - Copley Medical Center

Aurora, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

McFarland Clinic PC - Ames

Ames, Iowa, United States

Genesis Medical Center - East Campus

Davenport, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Ochsner Health Center-Summa

Baton Rouge, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Franklin Medical Center

Greenfield, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Hattiesburg Clinic - Hematology/Oncology Clinic

Hattiesburg, Mississippi, United States

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Cancer Research for the Ozarks NCORP

Springfield, Missouri, United States

Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, United States

Saint Vincent Healthcare

Billings, Montana, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

CHI Health Saint Francis

Grand Island, Nebraska, United States

Nebraska Methodist Hospital