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 currently recruiting participants.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01708941
First received: October 15, 2012
Last updated: December 6, 2013
Last verified: December 2013
  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, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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 Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Biological: ipilimumab
Biological: recombinant interferon alfa-2b
Other: laboratory biomarker analysis
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:
  • Progression-free survival (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:
  • Regimen limiting serious adverse events (AE), 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 (NCI CTCAE) v4.0 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ 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.

  • Response rate by RECIST and by immune-related response criteria (irRC) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • PFS for ipilimumab 10 mg/kg treatment in comparison to ipilimumab 3 mg/kg [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (10 mg/kg 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 five days a week for 4 weeks and then SC three 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 three times weekly for 48 weeks.

Biological: ipilimumab
Given IV
Other Names:
  • anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Biological: recombinant interferon alfa-2b
Given IV or SC
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Intron A
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm B (10 mg/kg 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
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm C (3 mg/kg 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 five days a week for 4 weeks and then SC three 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 three times weekly for 48 weeks.

Biological: ipilimumab
Given IV
Other Names:
  • anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Biological: recombinant interferon alfa-2b
Given IV or SC
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Intron A
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm D (3 mg/kg 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
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
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, 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)
  • 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 due to the unknown effects of ipilimumab and the combination with HDI on conception and the fetus; 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 due to the unknown effects of ipilimumab or the combination with HDI
  • 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) v1.1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708941

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Carla I. Falkson    205-934-0309      
Principal Investigator: Carla I. Falkson         
United States, Colorado
The Medical Center of Aurora Terminated
Aurora, Colorado, United States, 80012
Boulder Community Hospital Terminated
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare Terminated
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program CCOP Terminated
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital Terminated
Denver, Colorado, United States, 80218
Porter Adventist Hospital Terminated
Denver, Colorado, United States, 80210
Rose Medical Center Terminated
Denver, Colorado, United States, 80220
Saint Anthony Central Hospital Terminated
Denver, Colorado, United States, 80204
Presbyterian - Saint Lukes Medical Center - Health One Terminated
Denver, Colorado, United States, 80218
Swedish Medical Center Terminated
Englewood, Colorado, United States, 80110
North Colorado Medical Center Terminated
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital Terminated
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center Terminated
Lone Tree, Colorado, United States, 80124
Longmont United Hospital Terminated
Longmont, Colorado, United States, 80501
McKee Medical Center Terminated
Loveland, Colorado, United States, 80539
Parker Adventist Hospital Terminated
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center Terminated
Pueblo, Colorado, United States, 81004
Exempla Lutheran Medical Center Terminated
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Gregory A. Masters    302-733-6227      
Principal Investigator: Gregory A. Masters         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Gregory A. Masters    302-733-6227      
Principal Investigator: Gregory A. Masters         
Nanticoke Memorial Hospital Recruiting
Seaford, Delaware, United States, 19973
Contact: Gregory A. Masters    302-733-6227      
Principal Investigator: Gregory A. Masters         
United States, Georgia
Saint Joseph's-Candler Health System Recruiting
Savannah, Georgia, United States, 31405
Contact: Howard A. Zaren    800-622-6877      
Principal Investigator: Howard A. Zaren         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Illinois
Saint Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Mark F. Kozloff    708-915-4673    clinicaltrials@ingalls.org   
Principal Investigator: Mark F. Kozloff         
Hematology Oncology Associates of Illinois-Highland Park Recruiting
Highland Park, Illinois, United States, 60035
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
North Shore Hematology Oncology Recruiting
Libertyville, Illinois, United States, 60048
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Trinity Medical Center Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou    319-363-2690      
Principal Investigator: Costas L. Constantinou         
Illinois Cancer Specialists-Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Community Cancer Center Foundation Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Ottawa Regional Hospital and Healthcare Center Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois Oncology Research Association CCOP Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Swedish American Hospital Terminated
Rockford, Illinois, United States, 61104
SwedishAmerican Regional Cancer Center/ACT Recruiting
Rockford, Illinois, United States, 61107
Contact: Harvey E. Einhorn    779-696-9400    cancercare@swedishamerican.org   
Principal Investigator: Harvey E. Einhorn         
Hematology Oncology Associates of Illinois - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Timothy M. Kuzel    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Timothy M. Kuzel         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Carle Foundation - Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: James R. Egner    800-446-5532      
Principal Investigator: James R. Egner         
United States, Indiana
Saint Anthony Memorial Health Center Recruiting
Michigan City, Indiana, United States, 46360
Contact: James R. Egner    800-446-5532      
Principal Investigator: James R. Egner         
United States, Iowa
McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant    515-239-2621      
Principal Investigator: Joseph J. Merchant         
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Oncology Research Association CCOP Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates Recruiting
Des Moines, Iowa, United States, 50314
Contact: Robert J. Behrens    888-244-6061    sherrijr@iora.org   
Principal Investigator: Robert J. Behrens         
Mercy Medical Center-Sioux City Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Saint Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
Siouxland Hematology Oncology Associates Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender    712-252-0088      
Principal Investigator: Donald B. Wender         
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Main Office Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas-Wichita Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Associates In Womens Health Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil    316-262-4467      
Principal Investigator: Shaker R. Dakhil         
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Jyotsna Fuloria    888-562-4763      
Principal Investigator: Jyotsna Fuloria         
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Jyotsna Fuloria    888-562-4763      
Principal Investigator: Jyotsna Fuloria         
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jyotsna Fuloria    888-562-4763      
Principal Investigator: Jyotsna Fuloria         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Gary I. Cohen    443-849-3706      
Principal Investigator: Gary I. Cohen         
Union Hospital of Cecil County Terminated
Elkton MD, Maryland, United States, 21921
United States, Michigan
Hickman Cancer Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Michigan Cancer Research Consortium Community Clinical Oncology Program Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Oakwood Hospital Recruiting
Dearborn, Michigan, United States, 48124
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Community Cancer Center of Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Mercy Memorial Hospital Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Joseph Mercy Port Huron Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
Saint Mary's of Michigan Recruiting
Saginaw, Michigan, United States, 48601
Contact: Philip J. Stella    734-712-3456      
Principal Investigator: Philip J. Stella         
United States, Minnesota
Fairview-Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Saint John's Hospital - Healtheast Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Minnesota Oncology Hematology PA-Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Abbott-Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
North Memorial Medical Health Center Recruiting
Robbinsdale, Minnesota, United States, 55422
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Metro-Minnesota CCOP Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Park Nicollet Clinic - Saint Louis Park Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Saint Francis Regional Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Minnesota Oncology and Hematology PA-Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Nebraska
Lincoln Medical Education Foundation Cancer Resource Center Recruiting
Lincoln, Nebraska, United States, 68510
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Bergan Mercy Medical Center Recruiting
Omaha, Nebraska, United States, 68124
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Lakeside Hospital Recruiting
Omaha, Nebraska, United States, 68130
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
Alegent Health Immanuel Medical Center Recruiting
Omaha, Nebraska, United States, 68122
Contact: Gamini S. Soori    800-253-4368      
Principal Investigator: Gamini S. Soori         
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: Gregory A. Masters    302-733-6227      
Principal Investigator: Gregory A. Masters         
Veterans Adminstration New Jersey Health Care System Recruiting
East Orange, New Jersey, United States, 07018-1095
Contact: Basil S. Kasimis    800-475-2336    patricia.goyer@med.va.gov   
Principal Investigator: Basil S. Kasimis         
Hunterdon Medical Center Recruiting
Flemington, New Jersey, United States, 08822
Contact: Kenneth B. Blankstein    888-788-1260      
Principal Investigator: Kenneth B. Blankstein         
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Janice M. Mehnert    732-235-8675      
Principal Investigator: Janice M. Mehnert         
United States, New York
New York Oncology Hematology PC -Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Charles H. Weissman    518-489-3612 ext 1342    sharon.krause@usoncology.com   
Principal Investigator: Charles H. Weissman         
United States, Ohio
Summa Akron City Hospital Recruiting
Akron, Ohio, United States, 44304
Contact: Jennifer E. Payne    330-375-6101      
Principal Investigator: Jennifer E. Payne         
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook    216-778-8526    kbauchens@metrohealth.org   
Principal Investigator: Bruce J. Averbook         
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Toledo Clinic Cancer Centers-Maumee Recruiting
Maumee, Ohio, United States, 43537-1839
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Toledo Clinic Cancer Centers-Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Mercy Cancer Center at Saint Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Saint Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Clinic Cancer Centers-Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Toledo Community Hospital Oncology Program CCOP Recruiting
Toledo, Ohio, United States, 43617
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Rex B. Mowat    517-265-0116      
Principal Investigator: Rex B. Mowat         
Genesis HealthCare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
United States, Oklahoma
Natalie W Bryant Cancer Center Terminated
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2001
Contact: Christian S. Adonizio    570-271-5251      
Principal Investigator: Christian S. Adonizio         
Geisinger Medical Center-Cancer Center Hazelton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Christian S. Adonizio    570-271-5251      
Principal Investigator: Christian S. Adonizio         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Anthony J. Olszanski    215-728-4790      
Principal Investigator: Anthony J. Olszanski         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Ahmad A. Tarhini    412-647-8073      
Principal Investigator: Ahmad A. Tarhini         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: Christian S. Adonizio    570-271-5251      
Principal Investigator: Christian S. Adonizio         
Geisinger Wyoming Valley Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Christian S. Adonizio    570-271-5251      
Principal Investigator: Christian S. Adonizio         
United States, West Virginia
West Virginia University Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Steven J. Jubelirer    304-388-9944      
Principal Investigator: Steven J. Jubelirer         
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Mark R. Albertini    877-405-6866      
Principal Investigator: Mark R. Albertini         
Gundersen Lutheran Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kurt Oettel    608-775-2385    cancerctr@gundluth.org   
Principal Investigator: Kurt Oettel         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mark R. Albertini    877-405-6866      
Principal Investigator: Mark R. Albertini         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
Vince Lombardi Cancer Clinic-Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Wheaton Franciscan Healthcare - Saint Joseph Recruiting
Milwaukee, Wisconsin, United States, 53210
Contact: Jonathan S. Treisman    414-427-2360      
Principal Investigator: Jonathan S. Treisman         
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Stuart J. Wong    414-805-4380      
Principal Investigator: Stuart J. Wong         
Cancer Center of Western Wisconsin Recruiting
New Richmond, Wisconsin, United States, 54017
Contact: Joseph W. Leach    952-993-1517    MMCCOP@parknicollet.com   
Principal Investigator: Joseph W. Leach         
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Gerald K. Bayer    800-432-6049      
Principal Investigator: Gerald K. Bayer         
Vince Lombardi Cancer Clinic-Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Vince Lombardi Cancer Clinic Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Dhimant R. Patel    800-252-2990      
Principal Investigator: Dhimant R. Patel         
Aurora Cancer Care-Milwaukee West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Rubina Qamar    888-709-2080      
Principal Investigator: Rubina Qamar         
Sponsors and Collaborators
Investigators
Principal Investigator: Ahmad Tarhini Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01708941     History of Changes
Other Study ID Numbers: NCI-2012-01932, NCI-2012-01932, CDR0000741878, ECOG-E3611, E3611, E3611, U10CA021115
Study First Received: October 15, 2012
Last Updated: December 6, 2013
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
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Antibodies, Monoclonal
Reaferon
Cytotoxic T-lymphocyte antigen 4
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 15, 2014