This randomized phase II trial is studying how well giving ipilimumab with or without sargramostim (GM-CSF) works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery (unresectable). Ipilimumab works by activating the patient's immune system to fight cancer. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of treatment. It is not yet known whether giving ipilimumab together with sargramostim is more effective than ipilimumab alone in treating melanoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
* No more than one prior systemic therapeutic regimen for unresectable stage III or stage IV melanoma; this includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment; this does not include any therapies given in the adjuvant setting
* Histologic diagnosis of metastatic melanoma; for unknown primary disease, diagnosis of metastatic disease by cytology fine needle aspiration (FNA) is not acceptable
* Women must not be pregnant or breast-feeding due to unknown effects of ipilimumab and GM-CSF on the unborn fetus; all women of childbearing potential must have a blood test within 72 hours prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception; women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; sexually mature females who have not undergone a hysterectomy or who have not been postmenopausal naturally for at least 24 consecutive months (i.e., who have had menses at some time in the preceding 24 consecutive months) are considered to be of childbearing potential; women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
* White blood cells (WBC) \>= 2000/uL (obtained =\< 4 weeks prior to randomization)
* Absolute neutrophil count (ANC) \>= 1500/mcL (obtained =\< 4 weeks prior to randomization)
* Platelets \>= 100,000/mcL (obtained =\< 4 weeks prior to randomization)
* Hemoglobin \>= 8 g/dL (obtained =\< 4 weeks prior to randomization)
* Creatinine =\< 3.0 x upper limit of normal (ULN) (obtained =\< 4 weeks prior to randomization)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 4 weeks prior to randomization)
* Bilirubin =\< 3.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained =\< 4 weeks prior to randomization)
* No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids; must have been discontinued \>= 4 weeks
* No infection with human immunodeficiency virus (HIV); due to the mechanism of action of ipilimumab and GM-CSF, activity and side effects in an immune compromised patient are unknown
* No active infection with hepatitis B
* No active or chronic infection with hepatitis C
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
* Patients with any history of central nervous system (CNS) metastases are excluded
* Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
* Patients are excluded if they have a history of any autoimmune disease; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
* Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
* Patients are excluded for receiving any non-oncology vaccine therapy used for prevention of infectious diseases for up to four weeks (28 days) prior to or after any dose of ipilimumab
* Patients are excluded if they have a history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist
* Any concurrent medical condition requiring the use of systemic steroids is not permitted (the use of inhaled or topical steroids is permitted)
Primary outcome measure(s)
Overall Survival — Assessed every 3 months for 2 years, then every 6 months for 3 years Overall survival is defined as the time from randomization to death from any cause.
Trial sites (257)
Facility
City
Region
Status
University of Alabama at Birmingham Cancer Center
Birmingham
Alabama
Stanford Cancer Institute Palo Alto
Palo Alto
California
VA Palo Alto Health Care System
Palo Alto
California
Eisenhower Medical Center
Rancho Mirage
California
The Medical Center of Aurora
Aurora
Colorado
Boulder Community Foothills Hospital
Boulder
Colorado
Penrose-Saint Francis Healthcare
Colorado Springs
Colorado
AdventHealth Porter
Denver
Colorado
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Colorado
Saint Joseph Hospital - Cancer Centers of Colorado
Denver
Colorado
Rose Medical Center
Denver
Colorado
Western States Cancer Research NCORP
Denver
Colorado
Swedish Medical Center
Englewood
Colorado
Poudre Valley Hospital
Fort Collins
Colorado
Saint Mary's Hospital and Regional Medical Center
Grand Junction
Colorado
Banner North Colorado Medical Center
Greeley
Colorado
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood
Colorado
Sky Ridge Medical Center
Lone Tree
Colorado
Longmont United Hospital
Longmont
Colorado
Banner North Colorado Medical Center - Loveland Campus
Loveland
Colorado
Saint Mary Corwin Medical Center
Pueblo
Colorado
North Suburban Medical Center
Thornton
Colorado
Intermountain Health Lutheran Hospital
Wheat Ridge
Colorado
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Connecticut
Manchester Memorial Hospital
Manchester
Connecticut
The Hospital of Central Connecticut
New Britain
Connecticut
Yale University
New Haven
Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich
Connecticut
Beebe Medical Center
Lewes
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Delaware
Boca Raton Regional Hospital
Boca Raton
Florida
Lakeland Regional Health Hollis Cancer Center
Lakeland
Florida
21st Century Oncology-Orange Park
Orange Park
Florida
University Cancer and Blood Center LLC
Athens
Georgia
Emory University Hospital/Winship Cancer Institute
Atlanta
Georgia
Augusta University Medical Center
Augusta
Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Georgia
Rush-Copley Medical Center
Aurora
Illinois
MacNeal Hospital and Cancer Center
Berwyn
Illinois
OSF Saint Joseph Medical Center
Bloomington
Illinois
+ 217 more sites — see the full list on the official registry below.
More National Cancer Institute (NCI) trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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