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Chemioterapia di combinazione con o senza temsirolimus nel trattamento di pazienti con rabdomiosarcoma a rischio intermedio

30 settembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase 3 su vincristina, dactinomicina, ciclofosfamide (VAC) in alternanza con vincristina e irinotecan (VI) rispetto a VAC/VI più temsirolimus (TORI, Torisel, NSC# 683864) in pazienti con rabdomiosarcoma (RMS) a rischio intermedio (IR)

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVE:

I. To compare the event-free survival (EFS) of patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (irinotecan hydrochloride) (VI) (VAC/VI) with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

SECONDARY OBJECTIVE:

I. To compare the overall survival (OS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

EXPLORATORY OBJECTIVES:

I. To compare the outcome of patients based on their FOXO1 fusion gene partner, by evaluating PAX3 versus (vs) PAX7 in all patients found to be FOXO1 fusion positive.

II. To compare the outcome of patients based on their [F18]-fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) response at week 9 (positive or negative), as assessed by Deauville criteria (5-point).

III. To estimate the frequency of patients with circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at diagnosis and subsequent time-points, and explore whether tumor-specific somatic variants are detectable in the ctDNA.

IV. To compare the outcome of patients (VAC/VI with or without temsirolimus) who have received maintenance therapy on ARST1431 to those who received VAC/VI on ARST0531.

OUTLINE:

FEASIBILITY PHASE (THE FEASIBILITY PHASE IS COMPLETE, EFFECTIVE WITH AMENDMENT #1A): (< 21 years old): This is a dose-escalation study of temsirolimus.

Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Patients also undergo radiation therapy (RT) beginning week 13 for up to 6.5 weeks. Courses with temsirolimus repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

EFFICACY PHASE: Patients are randomized to Regimen A or B. Patients with disease that is ARMS FOXO1 fusion negative (stage I, group I/II, stage 1, group III [orbit] or stage II, group I/II) are assigned to Regimen C.

REGIMEN A (VAC/VI): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

REGIMEN B (VAC/VI TEMSIROLIMUS): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE (Patients in Regimen A or Regimen B): Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 6 cycles.

REGIMEN C (FOXO1 FUSION NEGATIVE): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually for up to 10 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

325

Fase

  • 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

  • Australia
    • New South Wales
      • Hunter Regional Mail Centre, New South Wales, Australia, 2310
        • John Hunter Children's Hospital
      • Randwick, New South Wales, Australia, 2031
        • Sydney Children's Hospital
      • Westmead, New South Wales, Australia, 2145
        • The Children's Hospital at Westmead
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Queensland Children's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6008
        • Princess Margaret Hospital for Children
      • Perth, Western Australia, Australia, 6009
        • Perth Children's Hospital
  • 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
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Jim Pattison Children's Hospital
  • Nuova Zelanda
      • Christchurch, Nuova Zelanda, 8011
        • Christchurch Hospital
    • Auckland
      • Grafton, Auckland, Nuova Zelanda, 1145
        • Starship Children's Hospital
  • Porto Rico
      • Caguas, Porto Rico, 00726
        • HIMA San Pablo Oncologic Hospital
      • San Juan, Porto Rico, 00926
        • University Pediatric Hospital
      • San Juan, Porto Rico, 00912
        • San Jorge Children's Hospital
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      • Birmingham, Alabama, Stati Uniti, 35233
        • Children's Hospital of Alabama
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        • USA Health Strada Patient Care Center
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        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Stati Uniti, 99508
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      • Anchorage, Alaska, Stati Uniti, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Stati Uniti, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Stati Uniti, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Stati Uniti, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Stati Uniti, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Stati Uniti, 99504
        • Anchorage Radiation Therapy Center
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      • Kingman, Arizona, Stati Uniti, 86401
        • Kingman Regional Medical Center
      • Mesa, Arizona, Stati Uniti, 85202
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        • Mayo Clinic Hospital in Arizona
      • Phoenix, Arizona, Stati Uniti, 85016
        • Phoenix Childrens Hospital
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        • Mayo Clinic in Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Banner University Medical Center - Tucson
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      • Little Rock, Arkansas, Stati Uniti, 72202-3591
        • Arkansas Children's Hospital
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        • PCR Oncology
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        • Kaiser Permanente-Bellflower
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        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
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        • Kaiser Permanente Downey Medical Center
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        • Kaiser Permanente-Fontana
      • Loma Linda, California, Stati Uniti, 92354
        • Loma Linda University Medical Center
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        • Children's Hospital Los Angeles
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        • UCLA / Jonsson Comprehensive Cancer Center
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        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Stati Uniti, 90095
        • Mattel Children's Hospital UCLA
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        • Valley Children's Hospital
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        • UCSF Benioff Children's Hospital Oakland
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        • 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
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        • Kaiser Permanente-Roseville
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        • 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 Diego, California, Stati Uniti, 92134
        • Naval Medical Center -San Diego
      • San Diego, California, Stati Uniti, 92108
        • Kaiser Permanente-Rio San Diego
      • San Francisco, California, Stati Uniti, 94158
        • UCSF Medical Center-Mission Bay
      • Santa Clara, California, Stati Uniti, 95051
        • Kaiser Permanente Medical Center - Santa Clara
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        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Children's Hospital Colorado
      • Denver, Colorado, Stati Uniti, 80218
        • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    • Connecticut
      • Hartford, Connecticut, Stati Uniti, 06106
        • Connecticut Children's Medical Center
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale University
      • New Haven, Connecticut, Stati Uniti, 06510
        • Smilow Cancer Center/Yale-New Haven Hospital
      • Trumbull, Connecticut, Stati Uniti, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
    • 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, 20002
        • Kaiser Permanente-Capitol Hill Medical Center
      • Washington D.C., District of Columbia, Stati Uniti, 20007
        • MedStar Georgetown University Hospital
      • Washington D.C., District of Columbia, Stati Uniti, 20016
        • Sibley Memorial Hospital
    • Florida
      • Fort Lauderdale, Florida, Stati Uniti, 33316
        • Broward Health Medical Center
      • 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
      • Loxahatchee Groves, Florida, Stati Uniti, 33470
        • Palms West Radiation Therapy
      • Miami, Florida, Stati Uniti, 33155
        • Nicklaus Children's Hospital
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, Stati Uniti, 33176
        • Miami Cancer Institute
      • 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
        • Sacred Heart Hospital
      • 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, 33606
        • Tampa General 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
      • Macon, Georgia, Stati Uniti, 31201
        • Atrium Health Navicent
      • 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
      • Fruitland, Idaho, Stati Uniti, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Stati Uniti, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Stati Uniti, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Stati Uniti, 83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Stati Uniti, 60612
        • University of Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Stati Uniti, 60611
        • Lurie Children's Hospital-Chicago
      • Chicago, Illinois, Stati Uniti, 60612
        • Rush MD Anderson Cancer Center
      • Maywood, Illinois, Stati Uniti, 60153
        • Loyola University Medical Center
      • 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
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Riley Hospital for Children
      • Indianapolis, Indiana, Stati Uniti, 46260
        • Ascension Saint Vincent Indianapolis Hospital
    • Iowa
      • Des Moines, Iowa, Stati Uniti, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Stati Uniti, 50309
        • Blank Children's Hospital
      • Des Moines, Iowa, Stati Uniti, 50316
        • Iowa Lutheran Hospital
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Stati Uniti, 40202
        • Norton Children's Hospital
    • 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
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts Children's Hospital
      • 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
      • East Lansing, Michigan, Stati Uniti, 48823
        • Michigan State University
      • 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
      • Lansing, Michigan, Stati Uniti, 48912
        • University of Michigan Health - Sparrow Lansing
      • 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
      • Wyoming, Michigan, Stati Uniti, 49519
        • University of Michigan Health - West
    • 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
      • City of Saint Peters, Missouri, Stati Uniti, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Columbia, Missouri, Stati Uniti, 65212
        • University of Missouri Children's Hospital
      • Creve Coeur, Missouri, Stati Uniti, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, Stati Uniti, 64108
        • Children's Mercy Hospitals and Clinics
      • St Louis, Missouri, Stati Uniti, 63110
        • Barnes-Jewish Hospital
      • St Louis, Missouri, Stati Uniti, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Stati Uniti, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Stati Uniti, 63104
        • Cardinal Glennon Children's Medical Center
    • Montana
      • Missoula, Montana, Stati Uniti, 59802
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Stati Uniti, 68114
        • Children's Hospital and Medical Center of Omaha
    • Nevada
      • Carson City, Nevada, Stati Uniti, 89703
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Stati Uniti, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Stati Uniti, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Stati Uniti, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Stati Uniti, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Stati Uniti, 89052
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Stati Uniti, 89074
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Stati Uniti, 89074
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Stati Uniti, 89074
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Stati Uniti, 89074
        • Oncology Las Vegas - Henderson
      • 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, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Stati Uniti, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Stati Uniti, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Stati Uniti, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Stati Uniti, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Stati Uniti, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Stati Uniti, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Stati Uniti, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Stati Uniti, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Stati Uniti, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Stati Uniti, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Stati Uniti, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Cancer and Blood Specialists-Tenaya
      • Las Vegas, Nevada, Stati Uniti, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Stati Uniti, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Stati Uniti, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Stati Uniti, 89074
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Stati Uniti, 89102
        • Desert West Surgery
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Stati Uniti, 89113
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Stati Uniti, 89169
        • University Cancer Center
      • Las Vegas, Nevada, Stati Uniti, 89113
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Stati Uniti, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Stati Uniti, 89183
        • OptumCare Cancer Care at Fort Apache
      • 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, 08903
        • Rutgers Cancer Institute of New Jersey
      • 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 Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Presbyterian Hospital
    • New York
      • Albany, New York, Stati Uniti, 12208
        • Albany Medical Center
      • Brooklyn, New York, Stati Uniti, 11219
        • Maimonides 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, 10065
        • Memorial Sloan Kettering Cancer Center
      • 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
      • Valhalla, New York, Stati Uniti, 10595
        • Westchester Medical Center
    • 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
      • Charlotte, North Carolina, Stati Uniti, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, Stati Uniti, 28207
        • Oncology Specialists of Charlotte
      • Charlotte, North Carolina, Stati Uniti, 28262
        • Southern Oncology Specialists-Charlotte
      • Charlotte, North Carolina, Stati Uniti, 28207
        • Novant Health Carolina Surgical - Randolph
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, Stati Uniti, 27834
        • East Carolina University
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Novant Health Cancer Institute - Huntersville
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Southern Oncology Specialists-Huntersville
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Novant Health Presbyterian Medical Center Huntersville
      • Matthews, North Carolina, Stati Uniti, 28105
        • Matthews Radiation Oncology Center
      • Matthews, North Carolina, Stati Uniti, 28105
        • Novant Health Cancer Institute - Matthews
      • Mooresville, North Carolina, Stati Uniti, 28117
        • Novant Health Cancer Institute - Mooresville
      • Salisbury, North Carolina, Stati Uniti, 28144
        • Novant Health Cancer Institute - Rowan
      • Salisbury, North Carolina, Stati Uniti, 28144
        • Rowan Regional 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
      • 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
      • Sylvania, Ohio, Stati Uniti, 43560
        • ProMedica Flower 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
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Saint Charles Health System
      • Clackamas, Oregon, Stati Uniti, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Stati Uniti, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Stati Uniti, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Stati Uniti, 97132
        • Providence Newberg Medical Center
      • Portland, Oregon, Stati Uniti, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Stati Uniti, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Stati Uniti, 97225
        • Providence Saint Vincent Medical Center
      • 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
      • 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
      • Boiling Springs, South Carolina, Stati Uniti, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
      • Clinton, South Carolina, Stati Uniti, 29325
        • Prisma Health Cancer Institute - Laurens
      • Columbia, South Carolina, Stati Uniti, 29203
        • Prisma Health Richland Hospital
      • Easley, South Carolina, Stati Uniti, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, Stati Uniti, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Stati Uniti, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Stati Uniti, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Stati Uniti, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Stati Uniti, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Stati Uniti, 29605
        • BI-LO Charities Children's Cancer Center
      • Greer, South Carolina, Stati Uniti, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, Stati Uniti, 29672
        • Prisma Health Cancer Institute - Seneca
    • 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
      • Knoxville, Tennessee, Stati Uniti, 37916
        • East Tennessee Childrens Hospital
      • Nashville, Tennessee, Stati Uniti, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Stati Uniti, 37203
        • The Children's Hospital at TriStar Centennial
    • Texas
      • Amarillo, Texas, Stati Uniti, 79106
        • Texas Tech University Health Sciences Center-Amarillo
      • Austin, Texas, Stati Uniti, 78723
        • Dell Children's Medical Center of Central Texas
      • 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
      • 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 Hospital
      • 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
      • Charlottesville, Virginia, Stati Uniti, 22908
        • University of Virginia Cancer Center
      • 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
    • Washington
      • Aberdeen, Washington, Stati Uniti, 98520
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Stati Uniti, 98004
        • Overlake Medical Center
      • Bellingham, Washington, Stati Uniti, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Stati Uniti, 98531
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Stati Uniti, 98026
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Stati Uniti, 98201
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Stati Uniti, 98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Stati Uniti, 99336
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Stati Uniti, 98503
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Stati Uniti, 98632
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, Stati Uniti, 98105
        • Seattle Children's Hospital
      • Seattle, Washington, Stati Uniti, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Stati Uniti, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Stati Uniti, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, Stati Uniti, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Stati Uniti, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Shelton, Washington, Stati Uniti, 98584
        • Providence Regional Cancer System-Shelton
      • Spokane, Washington, Stati Uniti, 99204
        • Providence Sacred Heart Medical Center and Children's Hospital
      • Spokane, Washington, Stati Uniti, 99204
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, Stati Uniti, 99218
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, Stati Uniti, 99216
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, Stati Uniti, 98405
        • Mary Bridge Children's Hospital and Health Center
      • Tacoma, Washington, Stati Uniti, 98431
        • Madigan Army Medical Center
      • Vancouver, Washington, Stati Uniti, 98664
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Stati Uniti, 99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Stati Uniti, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Stati Uniti, 98597
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Bridgeport, West Virginia, Stati Uniti, 26330
        • United Hospital Center
      • Charleston, West Virginia, Stati Uniti, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Martinsburg, West Virginia, Stati Uniti, 25401
        • WVUH-Berkely Medical Center
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Stati Uniti, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Stati Uniti, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • 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

Età idonea allo studio

Non più vecchio di 40 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1

  • Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment

  • Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below

  • RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants

    • ERMS

      • Stage 1, group III (non-orbit)
      • Stage 3, group I/II
      • Stage 2/3, group III
      • Stage 4, group IV, < 10 years old

    • ARMS:

      • Stages 1-3, groups I-III

  • Specimen Submission: Patients must have sufficient tissue available for the required biology study

  • Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky performance status score >= 50 for patients > 16 years of age

  • Peripheral absolute neutrophil count (ANC) >= 750/uL

  • Platelet count >= 75,000/uL

  • 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:

    • 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female)
    • 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female)
    • 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female)
    • 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female)
    • 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female)
    • 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female)
    • 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female)
    • >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female)
    • Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract

  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

  • 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 who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
  • Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment
  • Patients with uncontrolled hyperglycemia
  • Patients with uncontrolled hyperlipidemia
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed
  • Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs; Note: A pregnancy test is required for female patients of childbearing potential prior to study entry
  • Lactating females who plan to breastfeed their infants are not 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
Intervento / Trattamento
Sperimentale: Regimen A (VAC/VI)

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Altro: Laboratory Biomarker Analysis

Correlative studies

Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Altro: Questionnaire Administration

Ancillary studies

Droga: Cyclophosphamide

Given IV and PO

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
Biologico: Dactinomycin

Given IV

Altri nomi:
  • Cosmegen
  • Actinomicina A IV
  • Actinomicina C1
  • Actinomicina I1
  • Actinomicina IV
  • Actinomicina X 1
  • Actinomicina-[thr-val-pro-sar-meval]
  • DATTO
  • Dattinomicina
  • Lyovac Cosmegen
  • Merattinomicina
  • Actinomicina D
Droga: Irinotecan Hydrochloride

Given IV

Altri nomi:
  • Campto
  • Camptosar
  • U-101440E
  • CPT-11
  • Camptotecina 11
  • Camptotecina-11
  • CPT 11
  • Irinomedac
  • Irinotecan cloridrato triidrato
  • Irinotecan monocloridrato triidrato
  • CPT11
  • U101440E
Radiazione: Radiation Therapy

Undergo RT

Altri nomi:
  • Radioterapia del cancro
  • TIPO_ENERGIA
  • Irradiare
  • Irradiato
  • Irradiazione
  • Radiazione
  • Radioterapia, NAS
  • Radioterapia
  • RT
  • Terapia, radiazioni
  • Tipo di energia
Sperimentale: Regimen B (VAC/VI/temsirolimus)

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
Altro: Laboratory Biomarker Analysis

Correlative studies

Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Altro: Questionnaire Administration

Ancillary studies

Droga: Temsirolimus

Given IV

Altri nomi:
  • Torisel
  • CCI-779
  • Analogo della rapamicina CCI-779
  • Inibitore del ciclo cellulare 779
  • Analogo della rapamicina
  • CCI779
Droga: Cyclophosphamide

Given IV and PO

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
Biologico: Dactinomycin

Given IV

Altri nomi:
  • Cosmegen
  • Actinomicina A IV
  • Actinomicina C1
  • Actinomicina I1
  • Actinomicina IV
  • Actinomicina X 1
  • Actinomicina-[thr-val-pro-sar-meval]
  • DATTO
  • Dattinomicina
  • Lyovac Cosmegen
  • Merattinomicina
  • Actinomicina D
Droga: Irinotecan Hydrochloride

Given IV

Altri nomi:
  • Campto
  • Camptosar
  • U-101440E
  • CPT-11
  • Camptotecina 11
  • Camptotecina-11
  • CPT 11
  • Irinomedac
  • Irinotecan cloridrato triidrato
  • Irinotecan monocloridrato triidrato
  • CPT11
  • U101440E
Radiazione: Radiation Therapy

Undergo RT

Altri nomi:
  • Radioterapia del cancro
  • TIPO_ENERGIA
  • Irradiare
  • Irradiato
  • Irradiazione
  • Radiazione
  • Radioterapia, NAS
  • Radioterapia
  • RT
  • Terapia, radiazioni
  • Tipo di energia
Droga: Vinorelbine

Given IV

Altri nomi:
  • Diidrossideossinorvinkaleucoblastina
Sperimentale: Regimen C (FOXO1 fusion negative, VAC/VA)

Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Altro: Laboratory Biomarker Analysis

Correlative studies

Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Altro: Questionnaire Administration

Ancillary studies

Droga: Cyclophosphamide

Given IV and PO

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
Biologico: Dactinomycin

Given IV

Altri nomi:
  • Cosmegen
  • Actinomicina A IV
  • Actinomicina C1
  • Actinomicina I1
  • Actinomicina IV
  • Actinomicina X 1
  • Actinomicina-[thr-val-pro-sar-meval]
  • DATTO
  • Dattinomicina
  • Lyovac Cosmegen
  • Merattinomicina
  • Actinomicina D
Radiazione: Radiation Therapy

Undergo RT

Altri nomi:
  • Radioterapia del cancro
  • TIPO_ENERGIA
  • Irradiare
  • Irradiato
  • Irradiazione
  • Radiazione
  • Radioterapia, NAS
  • Radioterapia
  • RT
  • Terapia, radiazioni
  • Tipo di energia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Event-free Survival (EFS)
Lasso di tempo: Up to 3 years from study entry

The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death.
Up to 3 years from study entry

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Up to 3 years from study entry

The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death.
Up to 3 years from study entry

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Esito del paziente basato sul partner della proteina Forkhead Box O1 (FOXO1), valutando PAX3 rispetto a PAX7 in tutti i pazienti risultati positivi alla fusione FOXO1
Lasso di tempo: Fino a 10 anni
Fino a 10 anni
Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points
Lasso di tempo: Up to 10 years

Will determine the frequency with which of ctDNA is detected in patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) at diagnosis and how these levels change over time with. In addition, the level of ctDNA as a percent of total cell-free DNA will be summarized by reporting the median and range. Since no prior data are available on the rate of positivity nor the change over time, the analysis will be purely descriptive. Changes over time will be plotted to visually determine and compare the trajectories of ctDNA during the early and late stages of therapy.
Up to 10 years
Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response
Lasso di tempo: At week 9

Assessed by Deauville Criteria (5-point).
At week 9
Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531
Lasso di tempo: Up to 10 years

The two-sample log-rank test will be performed.
Up to 10 years

Collaboratori e investigatori

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

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Abha A Gupta, 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

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)

1 giugno 2016

Completamento primario (Effettivo)

30 giugno 2023

Completamento dello studio (Stimato)

27 ottobre 2026

Date di iscrizione allo studio

Primo inviato

2 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

2 ottobre 2015

Primo Inserito (Stimato)

5 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2015-01644
  • U10CA180886 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2015-01644 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • ARST1431 (Altro identificatore: CTEP)
  • ARST1431
  • ARST1431 (Altro identificatore: Children's Oncology Group)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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