Befejeződött1. fázis

Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Key facts

Where: Albuquerque, Ann Arbor, Asheville, Atlanta, Augusta, Aurora, Baltimore, Bethesda, Bethlehem, Birmingham, Boston, Chapel Hill, Charleston, Chattanooga, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Dallas, Dayton, Des Moines, Detroit, Downey, Duarte, Durham, Fort Myers, Fort Worth, Gainesville, Greenville, Hackensack, Hartford, Hollywood, Houston, Indianapolis, Jackson, Jacksonville, Kalamazoo, Kansas City, Knoxville, Las Vegas, Lebanon, Lexington, Livingston, Loma Linda, Los Angeles, Louisville, Madison, Marshfield, Maywood, Miami, Mineola, Minneapolis, Morristown, Nashville, New Brunswick, New Hyde Park, New Orleans, New York, Newark, Oakland, Oklahoma City, Omaha, Orange, Orlando, Palo Alto, Paterson, Pensacola, Peoria, Philadelphia, Pittsburgh, Portsmouth, Richmond, Rochester, Sacramento, San Antonio, San Diego, San Francisco, Savannah, Scarborough, Seattle, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tampa, The Bronx, Toledo, Washington D.C. és Wilmington, Egyesült ÁllamokSee the 113 sites
Phase: 1. fázis

Where in Egyesült Államok

University of New Mexico Cancer CenterAlbuquerque, Egyesült ÁllamokNo longer taking part
C S Mott Children's HospitalAnn Arbor, Egyesült ÁllamokNo longer taking part
Mission HospitalAsheville, Egyesült ÁllamokNo longer taking part
Children's Healthcare of Atlanta-EglestonAtlanta, Egyesült ÁllamokNo longer taking part
Augusta University Medical CenterAugusta, Egyesült ÁllamokNo longer taking part
Children's Hospital ColoradoAurora, Egyesült ÁllamokNo longer taking part
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, Egyesült ÁllamokNo longer taking part
Sinai Hospital of BaltimoreBaltimore, Egyesült ÁllamokNo longer taking part
Walter Reed National Military Medical CenterBethesda, Egyesült ÁllamokNo longer taking part
Lehigh Valley Hospital - MuhlenbergBethlehem, Egyesült ÁllamokNo longer taking part
Children's Hospital of AlabamaBirmingham, Egyesült ÁllamokNo longer taking part
Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
Massachusetts General Hospital Cancer CenterBoston, Egyesült ÁllamokNo longer taking part
Tufts Children's HospitalBoston, Egyesült ÁllamokNo longer taking part
UNC Lineberger Comprehensive Cancer CenterChapel Hill, Egyesült ÁllamokNo longer taking part
Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
T C Thompson Children's HospitalChattanooga, Egyesült ÁllamokNo longer taking part
Lurie Children's Hospital-ChicagoChicago, Egyesült ÁllamokNo longer taking part
University of Chicago Comprehensive Cancer CenterChicago, Egyesült ÁllamokNo longer taking part
University of IllinoisChicago, Egyesült ÁllamokNo longer taking part
Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
Cleveland Clinic FoundationCleveland, Egyesült ÁllamokNo longer taking part
Rainbow Babies and Childrens HospitalCleveland, Egyesült ÁllamokNo longer taking part
Columbia RegionalColumbia, Egyesült ÁllamokNo longer taking part
Prisma Health Richland HospitalColumbia, Egyesült ÁllamokNo longer taking part
Nationwide Children's HospitalColumbus, Egyesült ÁllamokNo longer taking part
UT Southwestern/Simmons Cancer Center-DallasDallas, Egyesült ÁllamokNo longer taking part
Dayton Children's HospitalDayton, Egyesült ÁllamokNo longer taking part
Blank Children's HospitalDes Moines, Egyesült ÁllamokNo longer taking part
Wayne State University/Karmanos Cancer InstituteDetroit, Egyesült ÁllamokNo longer taking part
Kaiser Permanente Downey Medical CenterDowney, Egyesült ÁllamokNo longer taking part
City of Hope Comprehensive Cancer CenterDuarte, Egyesült ÁllamokNo longer taking part
Duke University Medical CenterDurham, Egyesült ÁllamokNo longer taking part
Golisano Children's Hospital of Southwest FloridaFort Myers, Egyesült ÁllamokNo longer taking part
Lee Memorial Health SystemFort Myers, Egyesült ÁllamokNo longer taking part
Cook Children's Medical CenterFort Worth, Egyesült ÁllamokNo longer taking part
University of Florida Health Science Center - GainesvilleGainesville, Egyesült ÁllamokNo longer taking part
BI-LO Charities Children's Cancer CenterGreenville, Egyesült ÁllamokNo longer taking part
Hackensack University Medical CenterHackensack, Egyesült ÁllamokNo longer taking part
Connecticut Children's Medical CenterHartford, Egyesült ÁllamokNo longer taking part
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, Egyesült ÁllamokNo longer taking part
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
Ascension Saint Vincent Indianapolis HospitalIndianapolis, Egyesült ÁllamokNo longer taking part
Riley Hospital for ChildrenIndianapolis, Egyesült ÁllamokNo longer taking part
University of Mississippi Medical CenterJackson, Egyesült ÁllamokNo longer taking part
Nemours Children's Clinic-JacksonvilleJacksonville, Egyesült ÁllamokNo longer taking part
Bronson Methodist HospitalKalamazoo, Egyesült ÁllamokNo longer taking part
Children's Mercy Hospitals and ClinicsKansas City, Egyesült ÁllamokNo longer taking part
East Tennessee Childrens HospitalKnoxville, Egyesült ÁllamokNo longer taking part
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, Egyesült ÁllamokNo longer taking part
Nevada Cancer Research Foundation NCORPLas Vegas, Egyesült ÁllamokNo longer taking part
Summerlin Hospital Medical CenterLas Vegas, Egyesült ÁllamokNo longer taking part
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, Egyesült ÁllamokNo longer taking part
University of Kentucky/Markey Cancer CenterLexington, Egyesült ÁllamokNo longer taking part
Saint Barnabas Medical CenterLivingston, Egyesült ÁllamokNo longer taking part
Loma Linda University Medical CenterLoma Linda, Egyesült ÁllamokNo longer taking part
Children's Hospital Los AngelesLos Angeles, Egyesült ÁllamokNo longer taking part
Norton Children's HospitalLouisville, Egyesült ÁllamokNo longer taking part
University of Wisconsin Carbone Cancer Center - University HospitalMadison, Egyesült ÁllamokNo longer taking part
Marshfield Medical Center-MarshfieldMarshfield, Egyesült ÁllamokNo longer taking part
Loyola University Medical CenterMaywood, Egyesült ÁllamokNo longer taking part
Miami Cancer InstituteMiami, Egyesült ÁllamokNo longer taking part
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Egyesült ÁllamokNo longer taking part
NYU Langone Hospital - Long IslandMineola, Egyesült ÁllamokNo longer taking part
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Egyesült ÁllamokNo longer taking part
University of Minnesota/Masonic Cancer CenterMinneapolis, Egyesült ÁllamokNo longer taking part
Morristown Medical CenterMorristown, Egyesült ÁllamokNo longer taking part
Vanderbilt University/Ingram Cancer CenterNashville, Egyesült ÁllamokNo longer taking part
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, Egyesült ÁllamokNo longer taking part
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, Egyesült ÁllamokNo longer taking part
Children's Hospital New OrleansNew Orleans, Egyesült ÁllamokNo longer taking part
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
Newark Beth Israel Medical CenterNewark, Egyesült ÁllamokNo longer taking part
Kaiser Permanente-OaklandOakland, Egyesült ÁllamokNo longer taking part
UCSF Benioff Children's Hospital OaklandOakland, Egyesült ÁllamokNo longer taking part
University of Oklahoma Health Sciences CenterOklahoma City, Egyesült ÁllamokNo longer taking part
Children's Hospital and Medical Center of OmahaOmaha, Egyesült ÁllamokNo longer taking part
University of Nebraska Medical CenterOmaha, Egyesült ÁllamokNo longer taking part
Children's Hospital of Orange CountyOrange, Egyesült ÁllamokNo longer taking part
AdventHealth OrlandoOrlando, Egyesült ÁllamokNo longer taking part
Nemours Children's HospitalOrlando, Egyesült ÁllamokNo longer taking part
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, Egyesült ÁllamokNo longer taking part
Saint Joseph's Regional Medical CenterPaterson, Egyesült ÁllamokNo longer taking part
Nemours Children's Clinic - PensacolaPensacola, Egyesült ÁllamokNo longer taking part
Saint Jude Midwest AffiliatePeoria, Egyesült ÁllamokNo longer taking part
Children's Hospital of PhiladelphiaPhiladelphia, Egyesült ÁllamokNo longer taking part
Children's Hospital of Pittsburgh of UPMCPittsburgh, Egyesült ÁllamokNo longer taking part
Naval Medical Center - PortsmouthPortsmouth, Egyesült ÁllamokNo longer taking part
Virginia Commonwealth University/Massey Cancer CenterRichmond, Egyesült ÁllamokNo longer taking part
Mayo Clinic in RochesterRochester, Egyesült ÁllamokNo longer taking part
University of RochesterRochester, Egyesült ÁllamokNo longer taking part
University of California Davis Comprehensive Cancer CenterSacramento, Egyesült ÁllamokNo longer taking part
Methodist Children's Hospital of South TexasSan Antonio, Egyesült ÁllamokNo longer taking part
University of Texas Health Science Center at San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
Rady Children's Hospital - San DiegoSan Diego, Egyesült ÁllamokNo longer taking part
UCSF Medical Center-Mission BaySan Francisco, Egyesült ÁllamokNo longer taking part
UCSF Medical Center-ParnassusSan Francisco, Egyesült ÁllamokNo longer taking part
Memorial Health University Medical CenterSavannah, Egyesült ÁllamokNo longer taking part
Maine Children's Cancer ProgramScarborough, Egyesült ÁllamokNo longer taking part
Seattle Children's HospitalSeattle, Egyesült ÁllamokNo longer taking part
Providence Sacred Heart Medical Center and Children's HospitalSpokane, Egyesült ÁllamokNo longer taking part
Southern Illinois University School of MedicineSpringfield, Egyesült ÁllamokNo longer taking part
Mercy Hospital Saint LouisSt Louis, Egyesült ÁllamokNo longer taking part
Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
Johns Hopkins All Children's HospitalSt. Petersburg, Egyesült ÁllamokNo longer taking part
State University of New York Upstate Medical UniversitySyracuse, Egyesült ÁllamokNo longer taking part
Saint Joseph's Hospital/Children's Hospital-TampaTampa, Egyesült ÁllamokNo longer taking part
Montefiore Medical Center - Moses CampusThe Bronx, Egyesült ÁllamokNo longer taking part
Mercy Children's HospitalToledo, Egyesült ÁllamokNo longer taking part
ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, Egyesült ÁllamokNo longer taking part
Children's National Medical CenterWashington D.C., Egyesült ÁllamokNo longer taking part
MedStar Georgetown University HospitalWashington D.C., Egyesült ÁllamokNo longer taking part
Alfred I duPont Hospital for ChildrenWilmington, Egyesült ÁllamokNo longer taking part

Questions to ask the study team

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Are travel costs paid?
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Trial details

Who runs it: Children's Oncology Group
Trial code: NCT01798004
Record updated: 2024. július 15.
Original description: This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.Read full original descriptionShow less
Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma
This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
Inclusion: Patients must have a diagnosis of neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria; Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 are eligible with the following:; V-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or; Age > 18 months (> 547 days) regardless of biologic features or; Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid [DNA] index = 1) or any biologic feature that is indeterminate/unsatisfactory/unknown; Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:; MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or; Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status; Patients with newly diagnosed neuroblastoma with INSS stage 2A/2B with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features; Patients with newly diagnosed neuroblastoma with INSS stage 4S with MYCN amplification (> 4-fold increase in MYCN expression signals as compared to reference signals), regardless of additional biologic features; Patients >= 365 days initially diagnosed with neuroblastoma INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy; these patients must have been enrolled on ANBL00B1; study enrollment on ANBL12P1 must occur within 4 weeks of progression to stage 4 for INSS stage 1, 2, 4S; Patients must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology; 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:; Age 1 month to < 6 months: 0.4 mg/dL; Age 6 months to < 1 year: 0.5 mg/dL; Age 1 to < 2 years: 0.6 mg/dL; Age 2 to < 6 years: 0.8 mg/dL; Age 6 to < 10 years: 1 mg/dL; Age 10 to < 13 years: 1.2 mg/dL; Age 13 to < 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females); Age >= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females); Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and; Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN for age; Shortening fraction of >= 27% by echocardiogram, or; Ejection fraction of >= 50% by radionuclide evaluation; No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure; 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: Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible; Female patients who are pregnant are ineligible; Lactating females are not eligible unless they have agreed not to breastfeed their infants; Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained; Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.
ClinicalTrials.gov NCT01798004