Trial record 1 of 1 for:    E3611
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Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01708941
First received: October 15, 2012
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Recurrent Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interferon Alfa-2b
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The distribution of PFS will be compared using the log-rank test.


Secondary Outcome Measures:
  • OS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    OS data will be described for each treatment arm using the Kaplan-Meier method. OS will also be assessed for ipilimumab 10 mg/kg in comparison to ipilimumab 3 mg/kg.

  • PFS [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Will be assessed for ipilimumab 10 mg/kg treatment in comparison to ipilimumab 3 mg/kg.

  • Rate of regimen limiting serious adverse events (AEs), defined as grade 3 or higher immune mediated AE that require steroids or immunosuppressive therapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    The regimen limiting serious adverse events rate will be evaluated for each treatment arm.

  • Response rate by RECIST and by immune-related response criteria [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Response rate will also be assessed for ipilimumab 10 mg/kg in comparison to ipilimumab 3 mg/kg.


Estimated Enrollment: 88
Study Start Date: January 2013
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (higher dose ipilimumab, HDI)

INDUCTION 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.

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Recombinant Interferon Alfa-2b
Given IV or SC
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Interferon alfa 2b
  • INTERFERON ALFA-2B
  • Interferon Alpha-2b
  • Intron A
  • Sch 30500
  • Urifron
  • Viraferon
Experimental: Arm B (higher dose ipilimumab)

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.

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Arm C (lower dose ipilimumab + HDI)

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.

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Recombinant Interferon Alfa-2b
Given IV or SC
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Interferon alfa 2b
  • INTERFERON ALFA-2B
  • Interferon Alpha-2b
  • Intron A
  • Sch 30500
  • Urifron
  • Viraferon
Experimental: Arm D (lower dose ipilimumab)

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.

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (e.g., 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, Sjogren'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
  • 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
  • Hemoglobin >= 10 g/dL
  • Serum creatinine =< 1.8 mg/dl
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) for patients with liver metastases and =< 2.0 x ULN for patients without liver metastases
  • Serum bilirubin < 2 x ULN for patients with liver metastases and =< 1.5 x ULN for patients without liver metastases, (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL)
  • No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Patients must be free of brain metastasis by contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) scans within 4 weeks prior to enrollment; if known to have prior brain metastases, must not have evidence of active brain disease after definitive therapy (surgery, radiation therapy or stereotactic radiosurgery) on two successive MRI evaluations at least 3 months apart (one of which is =< 4 weeks prior to starting the study drugs)
  • All sites of disease must be evaluated within 4 weeks prior to randomization; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708941

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States, 80907
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Georgia
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Center of Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg Cottage Plaza Office
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Trinity Medical Center
Moline, Illinois, United States, 61265
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Valley Radiation Oncology
Peru, Illinois, United States, 61354
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Memorial Medical Center
Springfield, Illinois, United States, 62781
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
Springfield Clinic
Springfield, Illinois, United States, 62703
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States, 62226
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
United States, Indiana
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, United States, 46219
Woodland Cancer Care Center
Michigan City, Indiana, United States, 46360
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
United States, Iowa
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
McFarland Clinic PC-Boone
Boone, Iowa, United States, 50036
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States, 50501
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States, 50158
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49829
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48502
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Health Partners Inc
Minneapolis, Minnesota, United States, 55454
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States, 63670
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, United States, 63127
United States, Nebraska
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Oncology Hematology West
Omaha, Nebraska, United States, 68124
Oncology Hematology West PC
Omaha, Nebraska, United States, 68130
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Doctors Hospital
Columbus, Ohio, United States, 43228
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lancaster Radiation Oncology
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
University of Toledo
Toledo, Ohio, United States, 43614
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States, 17837
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States, 17901
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Aurora Cancer Care-Burlington
Burlington, Wisconsin, United States, 53105
Aurora Cancer Care-Southern Lakes
Elkhorn, Wisconsin, United States, 53121
Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin, United States, 54937
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States, 53024
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States, 53142
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Aurora Advanced Healthcare Inc-Menomonee Falls
Menomonee Falls, Wisconsin, United States, 53051
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Wheaton Franciscan Healthcare - Saint Joseph
Milwaukee, Wisconsin, United States, 53210
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States, 53209
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States, 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ahmad Tarhini ECOG-ACRIN Cancer Research Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01708941     History of Changes
Other Study ID Numbers: NCI-2012-01932  NCI-2012-01932  CDR0000741878  E3611  ECOG-E3611  E3611  E3611  U10CA180820  U10CA021115 
Study First Received: October 15, 2012
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-alpha
Antibodies, Monoclonal
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016