Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
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
7 other identifiers
interventional
88
1 country
277
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2013
Longer than P75 for phase_2
277 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
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedStudy Start
First participant enrolled
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2017
CompletedResults Posted
Study results publicly available
January 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2027
ExpectedMay 29, 2026
March 1, 2026
4.6 years
October 15, 2012
October 12, 2018
May 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
Secondary Outcomes (3)
Progression-free Survival
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
Overall Survival (OS)
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
Overall Survival
Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years
Other Outcomes (2)
Clinical Response Rate
Assessed every 12 weeks for 3 years
Immune-related Response Rate Per Immune-related Response Criteria
Assessed every 12 weeks for 3 years
Study Arms (4)
Arm A (higher dose ipilimumab, HDI)
EXPERIMENTALINDUCTION PHASE: Patients receive higher 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 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 (higher dose ipilimumab)
EXPERIMENTALINDUCTION 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 (lower dose ipilimumab + HDI)
EXPERIMENTALINDUCTION 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 (lower dose ipilimumab)
EXPERIMENTALINDUCTION 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.
Interventions
Given IV
Correlative studies
Given IV or SC
Eligibility Criteria
You may qualify if:
- Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed
- 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; however, patients are excluded if they have a history of prior treatment for melanoma (either adjuvant or metastatic disease) with ipilimumab or other cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, or prior interferon-alpha treatment for metastatic disease (history of adjuvant interferon-alpha is allowed); there should be a 4-week washout period between last treatment administration and initiation of study therapy
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibiotics
- Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
- Patients who have other current malignancies are not eligible; patients with other malignancies are eligible if they have been continuously disease free for \> 5 years prior to the time of randomization; one exception are patients treated with a curative intent and are continuously disease free for \> 3 years; these patients would be considered 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 with prior history of basal or squamous skin cancer are eligible
- Due to the possible effect of treatment with ipilimumab on the immunologic response to infectious disease vaccines, patients must not have had any infectious disease vaccination (e.g, standard influenza, H1N1 influenza, pneumococcal, meningococcal, tetanus toxoid) within 4 weeks prior to randomization
- Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy; NOTE: a woman of childbearing potential (WOCBP) is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months); for the purposes of this study, post-menopause is defined as:
- Amenorrhea \>= 24 consecutive months without another cause, or
- For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \>= 35 mIU/mL 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; men of fathering potential and WOCBP must be using an adequate method of contraception or must abstain from sexual intercourse to avoid conception/pregnancy throughout the study and for up to 26 weeks after the last dose of ipilimumab or HDI in such a manner that the risk of pregnancy is minimized; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
- White blood cells (WBC) \>= 3000/uL
- Absolute neutrophil count (ANC) \>= 1500/uL
- Platelets \>= 100 x 10\^3/uL
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (277)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, 61265, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62702, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, 46219, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, 68506, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Nebraska Cancer Specialists - Omaha
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Oncology Hematology West PC
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Regional West Medical Center Cancer Center
Scottsbluff, Nebraska, 69361, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
New York Oncology Hematology PC - Albany Medical Center
Albany, New York, 12208, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Delaware Radiation Oncology
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lancaster Radiation Oncology
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmad Tarhini
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 17, 2012
Study Start
January 18, 2013
Primary Completion
August 8, 2017
Study Completion (Estimated)
March 17, 2027
Last Updated
May 29, 2026
Results First Posted
January 11, 2019
Record last verified: 2026-03