Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery
Melanoma of Unknown Primary, Recurrent Melanoma, Stage IIIB Cutaneous Melanoma AJCC v7
About this trial
This is an interventional treatment trial for Melanoma of Unknown Primary
Eligibility Criteria
Inclusion Criteria:
All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan (with or without brain) and brain magnetic resonance imaging (MRI) or CT (if MRI is contraindicated); if PET-CT cannot be done, CT of neck, chest, abdomen, and pelvis should be done
- If for some reason a CT cannot be done, an MRI may be done instead; any other imaging studies if performed (eg, bone scan) must show no evidence of disease
Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages (2009 AJCC Melanoma Staging System):
Stage IIIB
- T1-4b N1a M0
- T1-4b N2a M0
- T1-4b N1b M0
- T1-4b N2b M0
- T1-4b N2c M0
Stage IIIC
- T1-4b N1b M0
- T1-4b N2b M0
- T1-4b N2c M0
- Any T N3 M0
Stage IV
- M1a
- M1b
- NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within 4 weeks prior to randomization
Patients with disease recurrence after adequate surgical excision of the original primary cutaneous/unknown primary melanoma are allowed even if they don't fit the strict staging criteria, but only as follows:
- Recurrence in a regional lymph node basin after a prior complete lymph node dissection; relapsed disease must be completely surgically resected with free margins
- Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins
- Recurrence in a regional lymph node basin; relapsed disease must be completely surgically resected with free margins
Patients with unknown primary melanoma (Tx) who present with cutaneous, subcutaneous, nodal and/or lung metastases that are completely surgically resected with free margins are allowed; these patients are allowed even if they don't fit the strict staging criteria; for stage IV patients LDH within the institutional ULN must be documented within 4 weeks prior to randomization (M1c is not eligible)
- NOTE: all subjects should be classified as IIIB, IIIC, M1a or M1b including subjects with disease recurrence after adequate surgical excision of the original primary melanoma; that is the treating team/physician investigator should review an overall TNM status (that includes primary tumor presentation and disease recurrence status) and provide a designation of IIIB, IIIC, M1a or M1b
Patients must be randomized within 84 days (12 weeks) of surgical resection; if more than one surgical procedure is required to render the patient disease-free, the patient must be randomized within 12 weeks of the last surgery
- NOTE: patients with clinically positive lymph nodes for melanoma involvement or those with positive lymph nodes identified through lymphoscintigraphic and/or dye lymphographic techniques in the groin, axilla, or neck should have additional lymphadenectomy in those sites; the complete lymph node dissection procedure would be considered as the last surgery in counting the 84 days unless a subsequent surgical procedure(s) was clinically required to ensure the disease free status
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support
- All females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy
Woman of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid 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; 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 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
- White blood cell (WBC) >= 3,000/uL (obtained within 4 weeks prior to randomization)
- Absolute neutrophil count (ANC) >= 1,500/uL (obtained within 4 weeks prior to randomization)
- Platelets >= 100 x 10^3/uL (obtained within 4 weeks prior to randomization)
- Hemoglobin >= 10 g/dL (obtained within 4 weeks prior to randomization)
- Serum creatinine =< 1.5 mg/dL (obtained within 4 weeks prior to randomization)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (obtained within 4 weeks prior to randomization)
- Serum bilirubin =< 1.5 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) (obtained within 4 weeks prior to randomization)
Exclusion Criteria:
Prior adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after the resection(s) that make(s) them eligible for this trial
- NOTE: previous radiation therapy, including after the surgical resection, is allowed as long as 21 days have elapsed between the radiation and initiation of this adjuvant systemic therapy
Prior treatment with anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) monoclonal antibodies or prior CTLA-4 inhibitor or agonist or prior clusters of differentiation (CD)137 agonist or prior interferon-alfa
- Other forms of prior treatment for melanoma (e.g., aldesleukin [IL-2], anti-tumor vaccine, chemotherapy) are allowed if given before the resection(s) that make(s) the patient eligible for this trial, but these must have been completed at least 4 weeks prior to randomization
- Active infection requiring current treatment with parenteral antibiotics
- 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 with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible
- Patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of interferon (IFN)-alfa or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alfa should be weighed very carefully in consultation with behavioral health or psychiatry
- Documented history of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or diverticulitis (history of diverticulosis is allowed)
Autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone) or continuous use of topical steroid creams or ointments or ophthalmologic steroids; a history of occasional (but not continuous) use of steroid inhalers is allowed; 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 investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study
- Exclusion from this study also includes patients with a history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis); other central nervous system (CNS) autoimmune disease (e.g., poliomyelitis, multiple sclerosis)
- Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible
- Prior infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within 4 weeks prior to randomization
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- 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; 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 melanoma in situ are eligible; patients with prior history of basal or squamous skin cancer are eligible; patients who have had multiple primary melanomas are eligible
Pregnant or breast-feeding
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: 1) 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); post-menopause is defined as:
- Amenorrhea >= 12 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 ; men or WOCBP who are unwilling or unable to strictly follow this requirement are not eligible
- A positive pregnancy test at baseline
- Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; patients must have negative testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) within 4 weeks prior to randomization
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Providence Hospital
- University of South Alabama Mitchell Cancer Institute
- Alaska Regional Hospital
- Providence Alaska Medical Center
- Fairbanks Memorial Hospital
- Banner MD Anderson Cancer Center
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Mercy Hospital Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- John L McClellan Memorial Veterans Hospital
- University of Arkansas for Medical Sciences
- Highlands Oncology Group - Rogers
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Sutter Davis Hospital
- Kaiser Permanente-Fremont
- Kaiser Permanente-Fresno
- Saint Jude Medical Center
- Marin Cancer Care Inc
- UC San Diego Moores Cancer Center
- The Angeles Clinic and Research Institute - West Los Angeles Office
- Mattel Children's Hospital UCLA
- UCLA / Jonsson Comprehensive Cancer Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Community Hospital of Monterey Peninsula
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Kaiser Permanente-Oakland
- Saint Joseph Hospital - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- Eisenhower Medical Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Sharp Memorial Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Presbyterian Intercommunity Hospital
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- UCHealth University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Kaiser Permanente-Franklin
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Shaw Cancer Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Manchester Memorial Hospital
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- AdventHealth Altamonte
- Boca Raton Regional Hospital
- Florida Hospital Memorial Medical Center
- Holy Cross Hospital
- University of Florida Health Science Center - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- AdventHealth Kissimmee
- Lakeland Regional Health Hollis Cancer Center
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- 21st Century Oncology-Orange Park
- AdventHealth Orlando
- Orlando Health Cancer Institute
- AdventHealth East Orlando
- Cancer Center of Putnam
- Memorial Hospital West
- Sacred Heart Hospital
- Martin Medical Center
- Robert and Carol Weissman Cancer Center at Martin Health
- Martin Hospital South
- Moffitt Cancer Center
- AdventHealth Winter Park
- University Cancer and Blood Center LLC
- Emory University Hospital/Winship Cancer Institute
- Atlanta Regional CCOP
- Northside Hospital
- Augusta University Medical Center
- John B Amos Cancer Center
- Northeast Georgia Medical Center-Gainesville
- Medical Center of Central Georgia
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- South Georgia Medical Center/Pearlman Cancer Center
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Joseph Regional Medical Center
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Mac Neal Hospital
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- Hematology and Oncology Associates
- Northwestern University
- Rush University Medical Center
- University of Illinois
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Advocate Illinois Masonic Medical Center
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Advocate Good Samaritan Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Advocate Sherman Hospital
- Ascension Alexian Brothers - Elk Grove Village
- Eureka Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- Ingalls Memorial Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- Hematology Oncology Associates of Illinois-Highland Park
- Edward Hines Jr VA Hospital
- Hinsdale Hematology Oncology Associates Incorporated
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- AMG Libertyville - Oncology
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Mid-Illinois Hematology Oncology Associates Limited
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Medical Center
- Swedish American Hospital
- OSF Saint Anthony Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Hematology Oncology Associates of Illinois - Skokie
- Illinois CancerCare-Spring Valley
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Community Cancer Center East
- Franciscan Health Indianapolis
- Community Cancer Center North
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- IU Health Ball Memorial Hospital
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- McFarland Clinic - Boone
- Physicians' Clinic of Iowa PC
- Saint Luke's Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer Center
- University of Iowa/Holden Comprehensive Cancer Center
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- MercyOne Waterloo Cancer Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- HaysMed University of Kansas Health System
- Hutchinson Regional Medical Center
- Cancer Center of Kansas-Independence
- University of Kansas Cancer Center-West
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- University of Kansas Cancer Center-Overland Park
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Ascension Via Christi - Pittsburg
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- Saint Joseph Radiation Oncology Resource Center
- University of Kentucky/Markey Cancer Center
- Jewish Hospital
- Owensboro Health Mitchell Memorial Cancer Center
- Mary Bird Perkins Cancer Center
- Ochsner Health Center-Summa
- Ochsner Health Center-Covington
- Ochsner LSU Health Monroe Medical Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Baptist Medical Center
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- Maine Center for Cancer Medicine-Scarborough
- York Hospital
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- Saint Agnes Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Christiana Care - Union Hospital
- Frederick Memorial Hospital
- Northwest Hospital Center
- Maryland Oncology Hematology PA-Aquilino Cancer Center
- TidalHealth Peninsula Regional
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Mass General/North Shore Cancer Center
- Berkshire Medical Center - Cancer Center
- Baystate Medical Center
- UMass Memorial Medical Center - University Campus
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- McLaren Cancer Institute-Clarkston
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Beaumont Hospital - Farmington Hills
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- West Michigan Cancer Center
- Sparrow Hospital
- McLaren Cancer Institute-Lapeer Region
- Trinity Health Saint Mary Mercy Livonia Hospital
- UP Health System Marquette
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- University of Mississippi Medical Center
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Veterans Administration
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Truman Medical Centers
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- The University of Kansas Cancer Center-South
- Research Medical Center
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Southeast Nebraska Cancer Center - 68th Street Place
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Regional West Medical Center Cancer Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- Renown Regional Medical Center
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Portsmouth Regional Hospital
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Hunterdon Medical Center
- Hackensack University Medical Center
- The Cancer Institute of New Jersey Hamilton
- Saint Barnabas Medical Center
- Morristown Medical Center
- Rutgers Cancer Institute of New Jersey
- Overlook Hospital
- Inspira Medical Center Vineland
- MD Anderson Cancer Center at Cooper-Voorhees
- University of New Mexico Cancer Center
- Presbyterian Kaseman Hospital
- New York Oncology Hematology PC - Albany
- New York Oncology Hematology PC - Albany Medical Center
- New York Oncology Hematology PC - Amsterdam
- Hematology Oncology Associates of Central New York-Auburn
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- New York Oncology Hematology PC - Clifton Park
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York-East Syracuse
- Glens Falls Hospital
- New York Oncology Hematology PC-Hudson
- Northwell Health NCORP
- Northwell Health/Center for Advanced Medicine
- Hematology Oncology Associates of Central New York-Liverpool
- North Shore University Hospital
- Garnet Health Medical Center
- Long Island Jewish Medical Center
- Mount Sinai Union Square
- Mount Sinai West
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- MidHudson Regional Hospital of Westchester Medical Center
- University of Rochester
- Hematology Oncology Associates of Central New York-Rome
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Hematology Oncology Associates of Central New York-Onondaga Hill
- New York Oncology Hematology PC - Troy
- Faxton-Saint Luke's Healthcare
- Atrium Health Stanly/LCI-Albemarle
- Randolph Hospital
- Mission Hospital
- Mountain Radiation Oncology PA
- AdventHealth Infusion Center Asheville
- Messino Cancer Centers
- Hope Women's Cancer Centers-Asheville
- Transylvania Regional Hospital
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- Atrium Health Cabarrus/LCI-Concord
- Duke University Medical Center
- Angel Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Cone Health Cancer Center
- East Carolina University
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kinston
- Mission Hospital McDowell
- Atrium Health Union/LCI-Union
- Annie Penn Memorial Hospital
- Rutherford Hospital
- Blue Ridge Regional Hospital
- Iredell Memorial Hospital
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Summa Health System - Barberton Campus
- Cleveland Clinic Cancer Center Beachwood
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Miami Valley Hospital South
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- The Christ Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center Independence
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Cleveland Clinic Cancer Center Strongsville
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- Cancer Care Associates-Norman
- University of Oklahoma Health Sciences Center
- Integris Southwest Medical Center
- Mercy Hospital Oklahoma City
- Mercy Physicians of Oklahoma-Lakeside
- Integris Cancer Institute of Oklahoma
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Oregon Health and Science University
- Mid-Columbia Medical Center/Celilo Cancer Center
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Geisinger Medical Center
- Delaware County Memorial Hospital
- Pocono Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- Armstrong Center for Medicine and Health
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Riddle Memorial Hospital
- Forbes Hospital
- Allegheny Valley Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Allegheny General Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Mercy Hospital
- Scranton Hematology Oncology
- Geisinger Medical Group
- Mount Nittany Medical Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- UPMC Susquehanna
- Lankenau Medical Center
- Main Line Health NCORP
- Rhode Island Hospital
- Miriam Hospital
- Roger Williams Medical Center
- AnMed Health Cancer Center
- AnMed Health Hospital
- Prisma Health Cancer Institute - Spartanburg
- Roper Hospital
- Charleston Oncology - Roper
- Charleston Oncology - Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Prisma Health Cancer Institute - Easley
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Carolina Blood and Cancer Care Associates PA
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Sanford USD Medical Center - Sioux Falls
- Erlanger Medical Center
- Memorial Hospital
- Jackson-Madison County General Hospital
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- University of Tennessee - Knoxville
- Vanderbilt University/Ingram Cancer Center
- Parkland Memorial Hospital
- Baylor University Medical Center
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- Scott and White Memorial Hospital
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont and State Agricultural College
- Fredericksburg Oncology Inc
- Hematology Oncology Associates of Fredericksburg Inc
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Cancer Care Center at Island Hospital
- MultiCare Auburn Medical Center
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Virginia Mason Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest Medical Specialties PLLC
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- Wenatchee Valley Hospital and Clinics
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- Saint Mary's Medical Center
- West Virginia University Healthcare
- Wheeling Hospital/Schiffler Cancer Center
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Saint Agnes Hospital/Agnesian Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Bellin Memorial Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Aurora Cancer Care-Milwaukee
- Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Ascension Saint Mary's Hospital
- Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Aspirus Cancer Care - Wisconsin Rapids
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Cross Cancer Institute
- CancerCare Manitoba
- Grand River Regional Cancer Centre at Grand River Hospital
- Ottawa Hospital and Cancer Center-General Campus
- Health Sciences North
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- University Health Network-Princess Margaret Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- CHUM - Centre Hospitalier de l'Universite de Montreal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm A (age >= 18, high-dose ipilimumab)
Arm B (age >= 18, recombinant interferon alfa-2b)
Arm C (age >= 18, low-dose ipilimumab)
Arm D (age 12-17, high-dose ipilimumab)
Arm E (ages 12-17, recombinant interferon alfa-2b)
Arm F (ages 12-17, low-dose ipilimumab)
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (closed accrual as of 4/4/14) (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cyclees in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)
Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)
Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (ages 12-17)