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Brief Title: Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
Official Title: A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination With High Dose Interferon-Alpha in Advanced Melanoma
Study ID: NCT01708941
Brief Summary: This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, may block tumor growth by targeting certain cells. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma.
Detailed Description: PRIMARY OBJECTIVES: I. Test the hypothesis that the combination of ipilimumab and high-dose interferon-alpha 2b (HDI \[recombinant interferon alfa-2b\]) will improve progression free survival (PFS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status). SECONDARY OBJECTIVES: I. Test the hypothesis that the combination of ipilimumab and HDI will prove to be safe and tolerable. II. Within the constraints of the sample size, attempt to test the hypotheses that (1) ipilimumab 10 mg/kg will lead to improved PFS in comparison to ipilimumab 3 mg/kg (across HDI treatment status); (2) the combination of ipilimumab and HDI will improve overall survival (OS) of patients with advanced metastatic melanoma as compared to ipilimumab alone (across ipilimumab treatment status) and (3) ipilimumab 10 mg/kg will lead to improved OS in comparison to ipilimumab 3 mg/kg (across HDI treatment status). OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM A: INDUCTION PHASE: Patients receive higher dose ipilimumab intravenously (IV) over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then subcutaneously (SC) 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks. ARM B: INDUCTION PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive higher dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24. ARM C: INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses and recombinant interferon alfa-2b IV over 20 minutes 5 days a week for 4 weeks and then SC 3 times weekly for 8 weeks. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24 and recombinant interferon alfa-2b SC 3 times weekly for 48 weeks. ARM D: INDUCTION PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 3 weeks for 4 doses. MAINTENANCE PHASE: Patients receive lower dose ipilimumab IV over 90 minutes once every 12 weeks for 4 doses beginning in week 24. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
SCL Health Saint Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Western States Cancer Research NCORP, Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Banner North Colorado Medical Center, Greeley, Colorado, United States
Saint Anthony Hospital, Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Banner McKee Medical Center, Loveland, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Rocky Mountain Cancer Centers-Parker, Parker, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC, Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
OSF Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States
AMG Libertyville - Oncology, Libertyville, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Spector, David MD (UIA Investigator), Moline, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Illinois CancerCare-Monmouth, Monmouth, Illinois, United States
Illinois Cancer Specialists-Niles, Niles, Illinois, United States
Carle Cancer Institute Normal, Normal, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Swedish American Hospital, Rockford, Illinois, United States
UW Health Carbone Cancer Center Rockford, Rockford, Illinois, United States
Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
IU Health Central Indiana Cancer Centers-East, Indianapolis, Indiana, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
Woodland Cancer Care Center, Michigan City, Indiana, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
McFarland Clinic - Boone, Boone, Iowa, United States
Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States
McFarland Clinic - Jefferson, Jefferson, Iowa, United States
McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Ochsner Health Center-Summa, Baton Rouge, Louisiana, United States
Ochsner Baptist Medical Center, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
OSF Saint Francis Hospital and Medical Group, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
University of Michigan Health - Sparrow Lansing, Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Nebraska Hematology and Oncology, Lincoln, Nebraska, United States
Nebraska Cancer Research Center, Lincoln, Nebraska, United States
Cancer Partners of Nebraska, Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States
Nebraska Cancer Specialists - Omaha, Omaha, Nebraska, United States
Alegent Health Lakeside Hospital, Omaha, Nebraska, United States
Oncology Hematology West PC, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Regional West Medical Center Cancer Center, Scottsbluff, Nebraska, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States
Hunterdon Medical Center, Flemington, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York Oncology Hematology PC - Albany Medical Center, Albany, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Summa Health System - Akron Campus, Akron, Ohio, United States
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
MetroHealth Medical Center, Cleveland, Ohio, United States
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center, Delaware, Ohio, United States
Delaware Radiation Oncology, Delaware, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lancaster Radiation Oncology, Lancaster, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Knox Community Hospital, Mount Vernon, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Newark Radiation Oncology, Newark, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
Southern Ohio Medical Center, Portsmouth, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
Mercy Health - Saint Vincent Hospital, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Health - Saint Anne Hospital, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Saint Ann's Hospital, Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Erlanger Medical Center, Chattanooga, Tennessee, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
West Virginia University Charleston Division, Charleston, West Virginia, United States
Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States
Aurora Health Center-Fond du Lac, Fond Du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center, Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
University of Wisconsin Carbone Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine, Racine, Wisconsin, United States
HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States
Aurora Cancer Care-Waukesha, Waukesha, Wisconsin, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Name: Ahmad Tarhini
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR