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

Completed · Phase 3 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01989572

Run by

National Cancer Institute (NCI)

People needed

815

Starts

2000-02-23

Expected to finish

2013-01-31

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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