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Chemioterapia di combinazione con o senza ganitumab nel trattamento di pazienti con sarcoma di Ewing metastatico di nuova diagnosi

21 ottobre 2026 aggiornato da: National Cancer Institute (NCI)

Studio randomizzato di fase 3 che valuta l'aggiunta dell'anticorpo monoclonale IGF-1R Ganitumab (AMG 479, NSC# 750008) alla chemioterapia multiagente per i pazienti con sarcoma di Ewing metastatico di nuova diagnosi

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.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Attivo, non reclutante

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

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 di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Effettivo)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
312

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

Non più vecchio di 50 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Regimen A (VDC/IE)

See Design Details.
Droga: Cyclophosphamide

Given IV

Altri nomi:
  • Cytoxan
  • CTX
  • (-)-ciclofosfamide
  • 2H-1,3,2-ossazafosforina, 2-[bis(2-cloroetil)ammino]tetraidro-, 2-ossido, monoidrato
  • Carloxan
  • Ciclofosfamidica
  • Ciclofosfamide
  • Ciclossale
  • Clafen
  • Clafene
  • CP monoidrato
  • Cella CYCLO
  • Cicloblastina
  • Ciclofosfame
  • Ciclofosfamide monoidrato
  • Ciclofosfamidum
  • Ciclofosfano
  • Ciclofosfanum
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuxale
  • Ledossina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamide
  • WR-138719
  • Asta B518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • Adriamicina
  • 5,12-naftacenedione, 10-[(3-ammino-2,3,6-trideossi-alfa-L-lisso-esopiranosil)ossi]-7,8, 9,10-tetraidro-6,8,11-triidrossi -8-(idrossiacetil)-1-metossi-, cloridrato, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamicina cloridrato
  • Adriamicina PFS
  • Adriamicina RDF
  • ADRIAMICINA, CLORIDRATO
  • Adriblastina
  • Adrimedac
  • Cloridrato di Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicina cloridrato
  • Doxorubicina.HCl
  • Doxorubina
  • Farmiblastina
  • FI 106
  • FI-106
  • idrossidaunorubicina
  • Rubex
  • FI106
Droga: Doxorubicin

Given IV

Altri nomi:
  • Adriablastina
  • Idrossidaunomicina
  • Idrossildaunorubicina
Droga: Vincristine

Given IV

Altri nomi:
  • Videoregistratore
  • Leurocristina
  • Vincristina
  • LCR
Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Droga: Etoposide

Given IV

Altri nomi:
  • Demetil Epipodofillotossina Etilidina Glucoside
  • EPEG
  • Ultimo
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP16213
  • VP-16213
Droga: Etoposide Phosphate

Given IV

Altri nomi:
  • Etopofos
Radiazione: External Beam Radiation Therapy

Undergo EBRT

Altri nomi:
  • EBRT
  • Radioterapia definitiva
  • Radiazione del raggio esterno
  • Radioterapia a fasci esterni
  • Trave esterna RT
  • radiazione esterna
  • Radioterapia esterna
  • radiazione a fascio esterno
  • Radiazione, Fascio Esterno
  • Teleradioterapia
  • Teleterapia
  • Radiazioni di teleterapia
  • Radioterapia a fasci esterni (convenzionale)
Droga: Ifosfamide

Given IV

Altri nomi:
  • Asta Z 4942
  • Asta Z-4942
  • Cifo
  • Holoxan
  • Olossano
  • Ifex
  • IFO
  • Cella IFO
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Ifosfamide
  • Iso-endossano
  • Isoendossano
  • Isofosfamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942
Radiazione: Stereotactic Radiosurgery

Undergo SBRT

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS
Procedura: Therapeutic Surgical Procedure

Undergo surgery
Sperimentale: 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

Altri nomi:
  • Cytoxan
  • CTX
  • (-)-ciclofosfamide
  • 2H-1,3,2-ossazafosforina, 2-[bis(2-cloroetil)ammino]tetraidro-, 2-ossido, monoidrato
  • Carloxan
  • Ciclofosfamidica
  • Ciclofosfamide
  • Ciclossale
  • Clafen
  • Clafene
  • CP monoidrato
  • Cella CYCLO
  • Cicloblastina
  • Ciclofosfame
  • Ciclofosfamide monoidrato
  • Ciclofosfamidum
  • Ciclofosfano
  • Ciclofosfanum
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuxale
  • Ledossina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamide
  • WR-138719
  • Asta B518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • Adriamicina
  • 5,12-naftacenedione, 10-[(3-ammino-2,3,6-trideossi-alfa-L-lisso-esopiranosil)ossi]-7,8, 9,10-tetraidro-6,8,11-triidrossi -8-(idrossiacetil)-1-metossi-, cloridrato, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamicina cloridrato
  • Adriamicina PFS
  • Adriamicina RDF
  • ADRIAMICINA, CLORIDRATO
  • Adriblastina
  • Adrimedac
  • Cloridrato di Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicina cloridrato
  • Doxorubicina.HCl
  • Doxorubina
  • Farmiblastina
  • FI 106
  • FI-106
  • idrossidaunorubicina
  • Rubex
  • FI106
Droga: Doxorubicin

Given IV

Altri nomi:
  • Adriablastina
  • Idrossidaunomicina
  • Idrossildaunorubicina
Droga: Vincristine

Given IV

Altri nomi:
  • Videoregistratore
  • Leurocristina
  • Vincristina
  • LCR
Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Droga: Etoposide

Given IV

Altri nomi:
  • Demetil Epipodofillotossina Etilidina Glucoside
  • EPEG
  • Ultimo
  • Toposar
  • Vepesid
  • PV 16
  • PV 16-213
  • VP-16
  • VP-16-213
  • VP16
  • VP16213
  • VP-16213
Droga: Etoposide Phosphate

Given IV

Altri nomi:
  • Etopofos
Radiazione: External Beam Radiation Therapy

Undergo EBRT

Altri nomi:
  • EBRT
  • Radioterapia definitiva
  • Radiazione del raggio esterno
  • Radioterapia a fasci esterni
  • Trave esterna RT
  • radiazione esterna
  • Radioterapia esterna
  • radiazione a fascio esterno
  • Radiazione, Fascio Esterno
  • Teleradioterapia
  • Teleterapia
  • Radiazioni di teleterapia
  • Radioterapia a fasci esterni (convenzionale)
Droga: Ifosfamide

Given IV

Altri nomi:
  • Asta Z 4942
  • Asta Z-4942
  • Cifo
  • Holoxan
  • Olossano
  • Ifex
  • IFO
  • Cella IFO
  • Ifolem
  • Ifomida
  • Ifomide
  • Ifosfamidum
  • Ifoxan
  • IFX
  • Ifosfamide
  • Iso-endossano
  • Isoendossano
  • Isofosfamide
  • Mitoxana
  • MJF 9325
  • MJF-9325
  • Naxamide
  • Seromida
  • Tronoxal
  • Z 4942
  • Z-4942
Radiazione: Stereotactic Radiosurgery

Undergo SBRT

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS
Procedura: Therapeutic Surgical Procedure

Undergo surgery

Biologico: Ganitumab

Given IV

Altri nomi:
  • AM 479
  • Anticorpo monoclonale umano anti-IGF-1R AMG-479
  • AMG-479
  • AMG479

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Event-free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 5 years after enrollment

Time from study enrollment to death or last patient contact.
5 years after enrollment
Frequency of Toxicity-events
Lasso di tempo: 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

Altre misure di risultato

Altre misure di risultato

Per gli studi clinici, una misurazione pianificata descritta nel protocollo utilizzata per determinare l'effetto di un intervento/trattamento sui partecipanti. Per gli studi osservazionali, una misurazione o un'osservazione utilizzata per descrivere modelli di malattie o tratti o associazioni con esposizioni, fattori di rischio o trattamento. I tipi di misure di esito includono la misura dell'esito primario e la misura dell'esito secondario.
Misura del risultato
Misura Descrizione
Lasso di tempo
Serum IGF Pathway Component and Tissue Protein, Deoxyribonucleic Acid (DNA), and Ribonucleic Acid Markers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
National Cancer Institute (NCI)

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Steven G DuBois, Children's Oncology Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
12 dicembre 2014

Completamento primario (Effettivo)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
31 marzo 2021

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
16 settembre 2027

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
1 dicembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
1 dicembre 2014

Primo Inserito (Stimato)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
3 dicembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
22 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
21 ottobre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • NCI-2014-02380
  • U10CA180886 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U10CA098543 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2014-02380 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • AEWS1221 (Altro identificatore: CTEP)
  • s15-00442
  • AEWS1221
  • AEWS1221 (Altro identificatore: Children's Oncology Group)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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