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Quimioterapia combinada con o sin ganitumab en el tratamiento de pacientes con sarcoma de Ewing metastásico recién diagnosticado

21 de octubre de 2026 actualizado por: National Cancer Institute (NCI)

Ensayo aleatorizado de fase 3 que evalúa la adición del anticuerpo monoclonal IGF-1R ganitumab (AMG 479, NSC n.º 750008) a la quimioterapia multifarmacológica para pacientes con sarcoma de Ewing metastásico recién diagnosticado

This randomized phase III trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Treatment with drugs that block the IGF-1R pathway, such as ganitumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether adding ganitumab to combination chemotherapy is more effective in treating patients with newly diagnosed metastatic Ewing sarcoma.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. To determine if event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy is improved with the addition of ganitumab (AMG 479).

SECONDARY OBJECTIVES:

I. To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma.

II. To compare overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.

EXPLORATORY OBJECTIVES:

I. To compare bone marrow response rates in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab.

II. To describe the toxicity of 6 months of ganitumab monotherapy as maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma.

III. To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg.

IV. To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma.

V. To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the insulin-like growth factor 1 (IGF-1) pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.

VI. To determine if EFS, overall survival, and bone marrow response rates differ based on protein, deoxyribose nucleic acid (DNA), and ribonucleic acid (RNA) marker in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab.

VII. To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma.

VIII. To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab.

IX. To investigate the ability of fludeoxyglucose F 18-positron emission tomography (FDG-PET) to augment conventional response assessment of primary Ewing sarcoma tumors by magnetic resonance imaging (MRI).

X. To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.

XI. To collect data on institutional testing for Ewing sarcoma breakpoint region 1 (EWSR1) translocation status in patients enrolling on study.

XII. To explore the capacity of plasma cell-free DNA analysis to detect tumor-specific genetic changes at initial diagnosis and after initiation of protocol therapy.

XIII. To collect a population of bone marrow metastatic tumor cells by flow cytometry for genomic profiling.

OUTLINE: Patients are randomized to 1 of 2 treatment regimens. (As of 3/20/2019, the study is closed to accrual and patients in Regimen B no longer receive ganitumab.)

REGIMEN A (vincristine sulfate, doxorubicin hydrochloride and cyclophosphamide [VDC] and ifosfamide and etoposide phosphate [IE]):

INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1, doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2, and cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 5, and 9, and ifosfamide IV over 1 hour on days 1 to 5 and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 7, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1, 7, 9, and 13; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 1 and 7, cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 7, 9, and 13, ifosfamide IV over 1 hour on days 1 to 5 of weeks 3, 5, 11, and 15, and etoposide phosphate IV over 1-2 hours on days 1 to 5 of weeks 3, 5, 11, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or external beam radiation therapy (EBRT).

REGIMEN B (VDC/IE + ganitumab):

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.

MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.

After completion of study treatment, patients are followed for 10 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

312

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
      • Québec, Canadá, G1V 4G2
        • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
    • Alberta
      • Calgary, Alberta, Canadá, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canadá, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6H 3V4
        • British Columbia Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canadá, A1B 3V6
        • Janeway Child Health Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Kingston, Ontario, Canadá, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canadá, N6A 5W9
        • Children's Hospital
      • Ottawa, Ontario, Canadá, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canadá, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canadá, H3H 1P3
        • The Montreal Children's Hospital of the MUHC
      • Montreal, Quebec, Canadá, H3T 1C5
        • Centre Hospitalier Universitaire Sainte-Justine
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Children's Hospital of Alabama
      • Mobile, Alabama, Estados Unidos, 36604
        • USA Health Strada Patient Care Center
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Mesa, Arizona, Estados Unidos, 85202
        • Banner Children's at Desert
      • Phoenix, Arizona, Estados Unidos, 85016
        • Phoenix Childrens Hospital
      • Tucson, Arizona, Estados Unidos, 85719
        • Banner University Medical Center - Tucson
      • Yuma, Arizona, Estados Unidos, 85364
        • Onvida Health Yuma Medical Center
    • Arkansas
      • Hot Springs, Arkansas, Estados Unidos, 71913
        • CHI Saint Vincent Cancer Center Hot Springs
      • Little Rock, Arkansas, Estados Unidos, 72202-3591
        • Arkansas Children's Hospital
    • California
      • Downey, California, Estados Unidos, 90242
        • Kaiser Permanente Downey Medical Center
      • Duarte, California, Estados Unidos, 91010
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, Estados Unidos, 92354
        • Loma Linda University Medical Center
      • Long Beach, California, Estados Unidos, 90806
        • Miller Children's and Women's Hospital Long Beach
      • Los Angeles, California, Estados Unidos, 90027
        • Children's Hospital Los Angeles
      • Madera, California, Estados Unidos, 93636
        • Valley Children's Hospital
      • Oakland, California, Estados Unidos, 94609
        • UCSF Benioff Children's Hospital Oakland
      • Oakland, California, Estados Unidos, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, Estados Unidos, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Estados Unidos, 94304
        • Lucile Packard Children's Hospital Stanford University
      • Sacramento, California, Estados Unidos, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Diego, California, Estados Unidos, 92123
        • Rady Children's Hospital - San Diego
      • San Francisco, California, Estados Unidos, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, Estados Unidos, 94143
        • UCSF Medical Center-Parnassus
      • Torrance, California, Estados Unidos, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Children's Hospital Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, Estados Unidos, 80218
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
      • Denver, Colorado, Estados Unidos, 80210
        • AdventHealth Porter
      • Durango, Colorado, Estados Unidos, 81301
        • Mercy Medical Center
      • Durango, Colorado, Estados Unidos, 81301
        • CommonSpirit Cancer Center Mercy
      • Golden, Colorado, Estados Unidos, 80401
        • Mountain Blue Cancer Care Center
      • Lakewood, Colorado, Estados Unidos, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Lakewood, Colorado, Estados Unidos, 80228
        • CommonSpirit Saint Anthony Hospital Cancer Center
      • Littleton, Colorado, Estados Unidos, 80122
        • AdventHealth Littleton
      • Longmont, Colorado, Estados Unidos, 80501
        • Longmont United Hospital
      • Longmont, Colorado, Estados Unidos, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Parker, Colorado, Estados Unidos, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Parker, Colorado, Estados Unidos, 80138
        • AdventHealth Parker
      • Pueblo, Colorado, Estados Unidos, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, Estados Unidos, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, Estados Unidos, 80260
        • Rocky Mountain Cancer Centers-Thornton
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale University
    • Delaware
      • Wilmington, Delaware, Estados Unidos, 19803
        • Alfred I duPont Hospital for Children
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Children's National Medical Center
      • Washington D.C., District of Columbia, Estados Unidos, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Fort Myers, Florida, Estados Unidos, 33908
        • Golisano Children's Hospital of Southwest Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, Estados Unidos, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, Estados Unidos, 32207
        • Nemours Children's Clinic-Jacksonville
      • Miami, Florida, Estados Unidos, 33155
        • Nicklaus Children's Hospital
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Orlando, Florida, Estados Unidos, 32827
        • Nemours Children's Hospital
      • Orlando, Florida, Estados Unidos, 32803
        • AdventHealth Orlando
      • Orlando, Florida, Estados Unidos, 32806
        • Arnold Palmer Hospital for Children
      • Pensacola, Florida, Estados Unidos, 32504
        • Nemours Children's Clinic - Pensacola
      • St. Petersburg, Florida, Estados Unidos, 33701
        • Johns Hopkins All Children's Hospital
      • Tampa, Florida, Estados Unidos, 33607
        • Saint Joseph's Hospital/Children's Hospital-Tampa
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Saint Mary's Medical Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30329
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
      • Augusta, Georgia, Estados Unidos, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Estados Unidos, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Estados Unidos, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Saint Luke's Cancer Institute - Boise
    • Illinois
      • Aurora, Illinois, Estados Unidos, 60504
        • Rush-Copley Medical Center
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Lurie Children's Hospital-Chicago
      • Danville, Illinois, Estados Unidos, 61832
        • Carle at The Riverfront
      • Effingham, Illinois, Estados Unidos, 62401
        • Carle Physician Group-Effingham
      • Mattoon, Illinois, Estados Unidos, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood, Illinois, Estados Unidos, 60153
        • Loyola University Medical Center
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • SSM Health Good Samaritan
      • Oak Lawn, Illinois, Estados Unidos, 60453
        • Advocate Children's Hospital-Oak Lawn
      • Park Ridge, Illinois, Estados Unidos, 60068
        • Advocate Children's Hospital-Park Ridge
      • Peoria, Illinois, Estados Unidos, 61637
        • OSF Children's Hospital of Illinois
      • Springfield, Illinois, Estados Unidos, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Estados Unidos, 62702
        • Saint John's Hospital
      • Springfield, Illinois, Estados Unidos, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Estados Unidos, 61801
        • The Carle Foundation Hospital
      • Yorkville, Illinois, Estados Unidos, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47713
        • Deaconess Clinic Downtown
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Riley Hospital for Children
      • Indianapolis, Indiana, Estados Unidos, 46260
        • Ascension Saint Vincent Indianapolis Hospital
      • Michigan City, Indiana, Estados Unidos, 46360
        • Franciscan Saint Anthony Health-Michigan City
      • Michigan City, Indiana, Estados Unidos, 46360
        • Woodland Cancer Care Center
      • Newburgh, Indiana, Estados Unidos, 47630
        • Chancellor Center for Oncology
    • Iowa
      • Clive, Iowa, Estados Unidos, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Estados Unidos, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, Estados Unidos, 51503
        • Alegent Health Mercy Hospital
      • Creston, Iowa, Estados Unidos, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Estados Unidos, 50309
        • Blank Children's Hospital
      • Des Moines, Iowa, Estados Unidos, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Iowa City, Iowa, Estados Unidos, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • West Des Moines, Iowa, Estados Unidos, 50266
        • Mercy Medical Center-West Lakes
    • Kentucky
      • Bardstown, Kentucky, Estados Unidos, 40004
        • CommonSpirit Saint Joseph Hospital - Bardstown
      • Corbin, Kentucky, Estados Unidos, 40701
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, Estados Unidos, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, Estados Unidos, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, Estados Unidos, 40509
        • CommonSpirit Saint Joseph Medical Center - East Lexington
      • London, Kentucky, Estados Unidos, 40741
        • CommonSpirit Saint Joseph Hospital London
      • Louisville, Kentucky, Estados Unidos, 40202
        • Jewish Hospital
      • Louisville, Kentucky, Estados Unidos, 40202
        • Norton Children's Hospital
      • Louisville, Kentucky, Estados Unidos, 40245
        • UofL Health Medical Center Northeast
      • Louisville, Kentucky, Estados Unidos, 40215
        • Saints Mary and Elizabeth Hospital
      • Shepherdsville, Kentucky, Estados Unidos, 40165
        • Jewish Hospital Medical Center South
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Estados Unidos, 70118
        • Children's Hospital New Orleans
    • Maine
      • Bangor, Maine, Estados Unidos, 04401
        • Eastern Maine Medical Center
      • Scarborough, Maine, Estados Unidos, 04074
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Estados Unidos, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Estados Unidos, 21201
        • University of Maryland/Greenebaum Cancer Center
      • Bethesda, Maryland, Estados Unidos, 20889-5600
        • Walter Reed National Military Medical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital Cancer Center
      • Springfield, Massachusetts, Estados Unidos, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, Estados Unidos, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • C S Mott Children's Hospital
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan Rogel Cancer Center
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Bronson Battle Creek
      • Detroit, Michigan, Estados Unidos, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Detroit, Michigan, Estados Unidos, 48236
        • Henry Ford Health Saint John Hospital
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Beacon Kalamazoo
      • Muskegon, Michigan, Estados Unidos, 49444
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Estados Unidos, 49120
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Port Huron, Michigan, Estados Unidos, 48060
        • Lake Huron Medical Center
      • Port Huron, Michigan, Estados Unidos, 48060
        • Huron Medical Center PC
      • Reed City, Michigan, Estados Unidos, 49677
        • Corewell Health Reed City Hospital
      • Royal Oak, Michigan, Estados Unidos, 48073
        • Corewell Health Children's
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
    • Minnesota
      • Duluth, Minnesota, Estados Unidos, 55805
        • Essentia Health Cancer Center
      • Minneapolis, Minnesota, Estados Unidos, 55404
        • Children's Hospitals and Clinics of Minnesota - Minneapolis
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic in Rochester
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Bolivar, Missouri, Estados Unidos, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Estados Unidos, 65616
        • Cox Cancer Center Branson
      • Columbia, Missouri, Estados Unidos, 65212
        • University of Missouri Children's Hospital
      • Joplin, Missouri, Estados Unidos, 64804
        • Freeman Health System
      • Joplin, Missouri, Estados Unidos, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Estados Unidos, 64108
        • Children's Mercy Hospitals and Clinics
      • Rolla, Missouri, Estados Unidos, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Estados Unidos, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Estados Unidos, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, Estados Unidos, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Estados Unidos, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Estados Unidos, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Estados Unidos, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Estados Unidos, 63104
        • Cardinal Glennon Children's Medical Center
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Nebraska Medicine-Bellevue
      • Grand Island, Nebraska, Estados Unidos, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Estados Unidos, 68847
        • CHI Health Good Samaritan
      • Kearney, Nebraska, Estados Unidos, 68845
        • Fred and Pamela Buffett Cancer Center - Kearney
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Saint Elizabeth Regional Medical Center
      • Omaha, Nebraska, Estados Unidos, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Estados Unidos, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Estados Unidos, 68118
        • Nebraska Medicine-Village Pointe
      • Omaha, Nebraska, Estados Unidos, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Estados Unidos, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Estados Unidos, 68114
        • Children's Hospital and Medical Center of Omaha
      • Omaha, Nebraska, Estados Unidos, 68122
        • Hematology and Oncology Consultants PC
      • Papillion, Nebraska, Estados Unidos, 68046
        • Midlands Community Hospital
    • Nevada
      • Carson City, Nevada, Estados Unidos, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Estados Unidos, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Estados Unidos, 89109
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Estados Unidos, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Estados Unidos, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Ann M Wierman MD LTD
      • Pahrump, Nevada, Estados Unidos, 89048
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Estados Unidos, 89502
        • Renown Regional Medical Center
      • Reno, Nevada, Estados Unidos, 89503
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Estados Unidos, 89509
        • Radiation Oncology Associates
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, Estados Unidos, 07960
        • Morristown Medical Center
      • New Brunswick, New Jersey, Estados Unidos, 08901
        • Saint Peter's University Hospital
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
      • Newark, New Jersey, Estados Unidos, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, Estados Unidos, 07503
        • Saint Joseph's Regional Medical Center
    • New York
      • Albany, New York, Estados Unidos, 12208
        • Albany Medical Center
      • Buffalo, New York, Estados Unidos, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Estados Unidos, 12801
        • Glens Falls Hospital
      • Mineola, New York, Estados Unidos, 11501
        • NYU Langone Hospital - Long Island
      • New Hyde Park, New York, Estados Unidos, 11040
        • The Steven and Alexandra Cohen Children's Medical Center of New York
      • New York, New York, Estados Unidos, 10029
        • Mount Sinai Hospital
      • New York, New York, Estados Unidos, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Estados Unidos, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
      • Stony Brook, New York, Estados Unidos, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Estados Unidos, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Estados Unidos, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Estados Unidos, 10467
        • Children's Hospital at Montefiore
      • The Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Estados Unidos, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Valhalla, New York, Estados Unidos, 10595
        • New York Medical College
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Mission Hospital
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Estados Unidos, 44308
        • Children's Hospital Medical Center of Akron
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Estados Unidos, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Estados Unidos, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Estados Unidos, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Estados Unidos, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Estados Unidos, 44106
        • Rainbow Babies and Childrens Hospital
      • Columbus, Ohio, Estados Unidos, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, Estados Unidos, 45404
        • Dayton Children's Hospital
      • Toledo, Ohio, Estados Unidos, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Estados Unidos, 97227
        • Legacy Emanuel Children's Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Estados Unidos, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Geisinger Medical Center
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State Children's Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Estados Unidos, 19134
        • Saint Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, Estados Unidos, 19102
        • Drexel University School of Medicine
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, Estados Unidos, 29203
        • Prisma Health Richland Hospital
      • Greenville, South Carolina, Estados Unidos, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Estados Unidos, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Estados Unidos, 29605
        • BI-LO Charities Children's Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
    • Tennessee
      • Chattanooga, Tennessee, Estados Unidos, 37403
        • T C Thompson Children's Hospital
      • Chattanooga, Tennessee, Estados Unidos, 37404
        • Memorial Hospital
      • Hixson, Tennessee, Estados Unidos, 37343
        • Pulmonary Medicine Center of Chattanooga-Hixson
      • Knoxville, Tennessee, Estados Unidos, 37916
        • East Tennessee Childrens Hospital
      • Memphis, Tennessee, Estados Unidos, 38105
        • Saint Jude Children's Research Hospital
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Estados Unidos, 37203
        • The Children's Hospital at TriStar Centennial
      • Ooltewah, Tennessee, Estados Unidos, 37363
        • Memorial GYN Plus
    • Texas
      • Austin, Texas, Estados Unidos, 78723
        • Dell Children's Medical Center of Central Texas
      • Bryan, Texas, Estados Unidos, 77802
        • Saint Joseph Regional Cancer Center
      • Corpus Christi, Texas, Estados Unidos, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, Estados Unidos, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Estados Unidos, 75230
        • Medical City Dallas Hospital
      • El Paso, Texas, Estados Unidos, 79905
        • El Paso Children's Hospital
      • Fort Worth, Texas, Estados Unidos, 76104
        • Cook Children's Medical Center
      • Houston, Texas, Estados Unidos, 77030
        • UT MD Anderson Cancer Center
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Lubbock, Texas, Estados Unidos, 79410
        • Covenant Children's Hospital
      • Lubbock, Texas, Estados Unidos, 79415
        • UMC Cancer Center / UMC Health System
      • Lubbock, Texas, Estados Unidos, 79430
        • Texas Tech University Health Sciences Center-Lubbock
      • San Antonio, Texas, Estados Unidos, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, Estados Unidos, 78207
        • Children's Hospital of San Antonio
      • San Antonio, Texas, Estados Unidos, 78229
        • Methodist Children's Hospital of South Texas
      • Temple, Texas, Estados Unidos, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84113
        • Primary Children's Hospital
    • Vermont
      • Berlin Corners, Vermont, Estados Unidos, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Estados Unidos, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Estados Unidos, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Falls Church, Virginia, Estados Unidos, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, Estados Unidos, 23507
        • Children's Hospital of The King's Daughters
      • Portsmouth, Virginia, Estados Unidos, 23708-2197
        • Naval Medical Center - Portsmouth
      • Richmond, Virginia, Estados Unidos, 23298
        • VCU Massey Comprehensive Cancer Center
      • Roanoke, Virginia, Estados Unidos, 24014
        • Carilion Children's
    • Washington
      • Burien, Washington, Estados Unidos, 98166
        • Saint Anne Hospital
      • Enumclaw, Washington, Estados Unidos, 98022
        • Saint Elizabeth Hospital
      • Federal Way, Washington, Estados Unidos, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, Estados Unidos, 98499
        • Saint Clare Hospital
      • Poulsbo, Washington, Estados Unidos, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, Estados Unidos, 98105
        • Seattle Children's Hospital
      • Silverdale, Washington, Estados Unidos, 98383
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
      • Spokane, Washington, Estados Unidos, 99204
        • Providence Sacred Heart Medical Center and Children's Hospital
      • Tacoma, Washington, Estados Unidos, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, Estados Unidos, 98405
        • Northwest Medical Specialties PLLC
      • Tacoma, Washington, Estados Unidos, 98431
        • Madigan Army Medical Center
      • Tacoma, Washington, Estados Unidos, 98405
        • Franciscan Research Center-Northwest Medical Plaza
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • West Virginia University Healthcare
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Marinette, Wisconsin, Estados Unidos, 54143
        • Saint Vincent Hospital Cancer Center at Marinette
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Children's Hospital of Wisconsin
  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • University Pediatric Hospital
      • San Juan, Puerto Rico, 00912
        • San Jorge Children's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

No mayor que 50 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site

  • For the purpose of this study metastatic disease is defined as one or more of the following:

    • Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor; skip lesions in the same bone as the primary tumor do not constitute metastatic disease; skip lesions in an adjacent bone are considered bone metastases; if there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed

    • Contralateral pleural effusion and/or contralateral pleural nodules

    • Distant lymph node involvement

    • Patients with pulmonary nodules are considered to have metastatic disease if the patient has:

      • Solitary nodule >= 0.5 cm or multiple nodules of >= 0.3 cm unless lesion is biopsied and negative for tumor
      • Patients with solitary nodule < 0.5 cm or multiple nodules < 0.3 cm are not considered to have lung metastasis unless biopsy documents tumor

    • Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on hematoxylin and eosin (H&E) stains; in the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse-transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study

      • This study requires bilateral bone marrow biopsies at study entry; the suggested approach for patients with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy)

    • Bone metastasis: This study utilizes whole body FDG-PET scans to screen patients for bone metastases; areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or computed tomography (CT) (whole body FDG-PET/CT or FDG-PET/magnetic resonance [MR] scan acceptable); whole body technetium bone scans may be performed at the discretion of the investigator and are not required; for patients without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry

  • Patients must have adequate tumor tissue to meet the minimum requirement for submission

  • Enrolling institutions are reminded that submission of pre-treatment serum, tumor tissue and whole blood is required

  • Patients should only have had a biopsy of the primary tumor without an attempt at complete or partial resection; patients will still be eligible if excision was attempted or accomplished as long as adequate anatomic imaging (MRI for most primary tumor sites) was obtained prior to surgery

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (performed within 7 days prior to enrollment):

    • Age < 6 months: Maximum serum creatinine (mg/dL): 0.4 for males and females
    • Age 6 months to < 1 year: Maximum serum creatinine (mg/dL): 0.5 for males and females
    • Age 1 to < 2 years: Maximum serum creatinine (mg/dL): 0.6 for males and females
    • Age 2 to < 6 years: Maximum serum creatinine (mg/dL): 0.8 for males and females
    • Age 6 to < 10 years: Maximum serum creatinine (mg/dL): 1 for males and females
    • Age 10 to < 13 years: Maximum serum creatinine (mg/dL): 1.2 for males and females
    • Age 13 to < 16 years: Maximum serum creatinine (mg/dL): 1.5 for males and 1.4 for females
    • Age >= 16 years: Maximum serum creatinine (mg/dL): 1.7 for males and 1.4 for females

  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment), and

  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment) (except for patients with liver metastasis who may enroll if ALT < 5 times ULN for age)

  • Shortening fraction of >= 27% or

  • Ejection fraction of >= 50%

  • Patients must have a normal blood sugar level for age to participate; if an initial random draw (ie. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw

  • All patients and/or their parents or legal guardians must sign a written informed consent

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with regional node involvement as their only site of disease beyond the primary tumor will not be eligible
  • Patients whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord) are not eligible
  • Patients who have received prior chemotherapy or radiation therapy are not eligible
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of protocol therapy; sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of protocol therapy
  • Patients with known pre-existing diabetes mellitus will be excluded from study
  • Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > 3 weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< 3 weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Regimen A (VDC/IE)

See Design Details.
Droga: Cyclophosphamide

Given IV

Otros nombres:
  • Citoxano
  • CTX
  • (-)-ciclofosfamida
  • 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato
  • Carloxano
  • Ciclofosfamida
  • Cicloxal
  • Clafen
  • Clafeno
  • CP monohidrato
  • Célula CYCLO
  • Cicloblastina
  • Ciclofosfano
  • Monohidrato de ciclofosfamida
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuina
  • Ledoxina
  • Mitoxano
  • Neosar
  • Revimmune
  • Siklofosfamid
  • WR-138719
  • Asta B 518
  • B-518
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Otros nombres:
  • Adriamicina
  • 5,12-naftacenodiona, 10-[(3-amino-2,3,6-tridesoxi-alfa-L-lixo-hexopiranosil)oxi]-7,8, 9,10-tetrahidro-6,8,11-trihidroxi -8-(hidroxiacetil)-1-metoxi-, clorhidrato, (8S-cis)- (9CI)
  • ADM
  • Adriacina
  • Clorhidrato de adriamicina
  • Adriamicina SLP
  • Adriamicina RDF
  • ADRIAMICINA, CLORHIDRATO
  • Adriblastina
  • Adrímedac
  • Clorhidrato de doxorrubicina
  • DOX
  • CÉLULA DOXO
  • Doxolema
  • Doxorrubicina.HCl
  • Doxorrubina
  • Farmiblastina
  • FI 106
  • FI-106
  • hidroxidaunorrubicina
  • Rubéx
  • FI106
Droga: Doxorubicin

Given IV

Otros nombres:
  • Adriblastina
  • Hidroxidaunomicina
  • Hidroxil daunorrubicina
  • Hidroxildaunorrubicina
Droga: Vincristine

Given IV

Otros nombres:
  • Vídeo
  • Leurocristina
  • Vincristina
  • LCR
Droga: Vincristine Sulfate

Given IV

Otros nombres:
  • Oncovin
  • Kyocristina
  • Sulfato de leurocristina
  • Leurocristina, sulfato
  • Vincasar
  • Vincósido
  • Vincrex
  • Vincristina, sulfato
Droga: Etoposide

Given IV

Otros nombres:
  • Demetil Epipodofilotoxina Etilidina Glucósido
  • EPEG
  • Último
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • Vicepresidente 16213
  • VP-16213
  • VP16213
Droga: Etoposide Phosphate

Given IV

Otros nombres:
  • Etopós
Radiación: External Beam Radiation Therapy

Undergo EBRT

Otros nombres:
  • EBRT
  • Radioterapia definitiva
  • Radiación de haz externo
  • Radioterapia de haz externo
  • Haz externo RT
  • radiación externa
  • Radioterapia externa
  • radiación de haz externo
  • Radiación, haz externo
  • Teleradioterapia
  • Teleterapia
  • Radiación de teleterapia
  • Radioterapia de haz externo (convencional)
Droga: Ifosfamide

Given IV

Otros nombres:
  • Asta z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxano
  • Ifex
  • IFO
  • Célula IFO
  • Ifolem
  • Ifomida
  • Ifosfamidum
  • Ifoxán
  • IFX
  • Ifosfamida
  • Iso-endoxano
  • Isoendoxano
  • Isofosfamida
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamida
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942
Radiación: Stereotactic Radiosurgery

Undergo SBRT

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS
Procedimiento: Therapeutic Surgical Procedure

Undergo surgery
Experimental: Regimen B (VDC/IE + ganitumab)

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.

LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.

CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.

METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.

MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.
Droga: Cyclophosphamide

Given IV

Otros nombres:
  • Citoxano
  • CTX
  • (-)-ciclofosfamida
  • 2H-1,3,2-oxazafosforina, 2-[bis(2-cloroetil)amino]tetrahidro-, 2-óxido, monohidrato
  • Carloxano
  • Ciclofosfamida
  • Cicloxal
  • Clafen
  • Clafeno
  • CP monohidrato
  • Célula CYCLO
  • Cicloblastina
  • Ciclofosfano
  • Monohidrato de ciclofosfamida
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuina
  • Ledoxina
  • Mitoxano
  • Neosar
  • Revimmune
  • Siklofosfamid
  • WR-138719
  • Asta B 518
  • B-518
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Otros nombres:
  • Adriamicina
  • 5,12-naftacenodiona, 10-[(3-amino-2,3,6-tridesoxi-alfa-L-lixo-hexopiranosil)oxi]-7,8, 9,10-tetrahidro-6,8,11-trihidroxi -8-(hidroxiacetil)-1-metoxi-, clorhidrato, (8S-cis)- (9CI)
  • ADM
  • Adriacina
  • Clorhidrato de adriamicina
  • Adriamicina SLP
  • Adriamicina RDF
  • ADRIAMICINA, CLORHIDRATO
  • Adriblastina
  • Adrímedac
  • Clorhidrato de doxorrubicina
  • DOX
  • CÉLULA DOXO
  • Doxolema
  • Doxorrubicina.HCl
  • Doxorrubina
  • Farmiblastina
  • FI 106
  • FI-106
  • hidroxidaunorrubicina
  • Rubéx
  • FI106
Droga: Doxorubicin

Given IV

Otros nombres:
  • Adriblastina
  • Hidroxidaunomicina
  • Hidroxil daunorrubicina
  • Hidroxildaunorrubicina
Droga: Vincristine

Given IV

Otros nombres:
  • Vídeo
  • Leurocristina
  • Vincristina
  • LCR
Droga: Vincristine Sulfate

Given IV

Otros nombres:
  • Oncovin
  • Kyocristina
  • Sulfato de leurocristina
  • Leurocristina, sulfato
  • Vincasar
  • Vincósido
  • Vincrex
  • Vincristina, sulfato
Droga: Etoposide

Given IV

Otros nombres:
  • Demetil Epipodofilotoxina Etilidina Glucósido
  • EPEG
  • Último
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • Vicepresidente 16213
  • VP-16213
  • VP16213
Droga: Etoposide Phosphate

Given IV

Otros nombres:
  • Etopós
Radiación: External Beam Radiation Therapy

Undergo EBRT

Otros nombres:
  • EBRT
  • Radioterapia definitiva
  • Radiación de haz externo
  • Radioterapia de haz externo
  • Haz externo RT
  • radiación externa
  • Radioterapia externa
  • radiación de haz externo
  • Radiación, haz externo
  • Teleradioterapia
  • Teleterapia
  • Radiación de teleterapia
  • Radioterapia de haz externo (convencional)
Droga: Ifosfamide

Given IV

Otros nombres:
  • Asta z 4942
  • Asta Z-4942
  • Cyfos
  • Holoxano
  • Ifex
  • IFO
  • Célula IFO
  • Ifolem
  • Ifomida
  • Ifosfamidum
  • Ifoxán
  • IFX
  • Ifosfamida
  • Iso-endoxano
  • Isoendoxano
  • Isofosfamida
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamida
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942
Radiación: Stereotactic Radiosurgery

Undergo SBRT

Otros nombres:
  • Irradiación estereotáctica de haz externo
  • radioterapia estereotáctica de haz externo
  • Radioterapia estereotáctica
  • radioterapia estereotáxica
  • radiocirugía estereotáxica
  • SRS
Procedimiento: Therapeutic Surgical Procedure

Undergo surgery

Biológico: Ganitumab

Given IV

Otros nombres:
  • AMG 479
  • Anticuerpo monoclonal humano anti-IGF-1R AMG-479
  • AMG-479
  • AMG479

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Event-free Survival
Periodo de tiempo: 5 years after enrollment

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
5 years after enrollment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival
Periodo de tiempo: 5 years after enrollment

Time from study enrollment to death or last patient contact.
5 years after enrollment
Frequency of Toxicity-events
Periodo de tiempo: Up to 202 days

The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.
Up to 202 days

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
Periodo de tiempo: Up to 10 years

In addition to the log rank test the modeling approach will be used for the primary study comparison. Linear trend in EFS-risk will be investigated by segregating the marker level according to quartiles. For bone marrow response rate analyses, Fisher's exact test will be used to compare the objective bone marrow response rate (complete response vs. incomplete response) at start of local control between patients with biomarker levels above and below the group median.
Up to 10 years
Tumor Cell Surface IGF-1R Expression
Periodo de tiempo: Up to 307 days

Extent of tumor cell IGF-1R co-expression will also be reported. Change in tumor cell IGF-1R co-expression in patients treated with and without ganitumab will be reported descriptively.
Up to 307 days
Germline Polymorphisms in EGFR
Periodo de tiempo: Up to 10 years

EFS will be compared between patients with and without the presence of the minor allele using the log rank test, both for the entire patient population and for patients randomized to ganitumab.
Up to 10 years
EWS Translocation
Periodo de tiempo: Up to 10 years

The institutional result of EWS tumor testing will be categorized as translocation detected (yes v. no) and the type of translocation detected will also be recorded. The proportion of patients with a particular EWS translocation variant will be tabulated.
Up to 10 years
Circulating Tumor DNA (ctDNA) Testing
Periodo de tiempo: Up to 202 days

Will report the proportion of patients that have a change in translocation result associated with ctDNA testing across time periods.
Up to 202 days
Serial Genomic Profiling
Periodo de tiempo: Up to 307 days

Will be identified by flow cytometry. Profiles will be presented graphically, and samples obtained from different sites of tumor within the same individual will also be presented.
Up to 307 days
Occurrence of Sinusoidal Obstructive Disease (SOS) Associated With the Addition of Ganitumab to VDC/IE
Periodo de tiempo: Up to 202 days

The number of induction and maintenance cycles received by patients randomized to the experimental therapy where SOS is observed. Only patients who receive all reporting period therapy or experience SOS will contribute to this outcome measure.
Up to 202 days
Frequency of Resolution of Bone Marrow Metastases
Periodo de tiempo: Up to 84 days

The number of patients who are enrolled with bone marrow metastases whose bone marrow disease is not detected after evaluation at the time of of first local control measure or the end of the Induction reporting period, whichever comes first. Only eligible patients who receive at least one dose of randomized treatment assignment will be considered for this measure.
Up to 84 days
Frequency of Toxicity Events During Ganitumab Maintenance
Periodo de tiempo: Up to 307 days

The number of induction or consolidation reporting periods in which a CTC version 4 codeable non-hematological adverse event, grade 3 left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.
Up to 307 days
Trough Levels of Serum Ganitumab
Periodo de tiempo: Up to 15 days

Trough levels of serum ganitumab prior to the second dose of ganitumab during induction obtained will be categorized as less than 10 micrograms per milliliter or greater than or equal to 10 micrograms per milliliter. This analysis will be conducted for the first 10 eligible patients who receive ganitumab.
Up to 15 days
Proportion of Patients Who Successfully Receive Planned Stereotactic Body Radiotherapy (SBRT)
Periodo de tiempo: 202 days

A patient who has SBRT planned for at least one metastatic site and receives successful SBRT treatment to at least 85% of metastatic sites in the treatment plan. Successful treatment is determined by IROC review criteria. Only eligible patients start the metastatic site radiation reporting period will be considered for this outcome measure.
202 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Steven G DuBois, Children's Oncology Group

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de diciembre de 2014

Finalización primaria (Actual)

31 de marzo de 2021

Finalización del estudio (Estimado)

16 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de diciembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

1 de diciembre de 2014

Publicado por primera vez (Estimado)

3 de diciembre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de octubre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2014-02380
  • U10CA180886 (Subvención/contrato del NIH de EE. UU.)
  • U10CA098543 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2014-02380 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • AEWS1221 (Otro identificador: CTEP)
  • s15-00442
  • AEWS1221
  • AEWS1221 (Otro identificador: Children's Oncology Group)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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