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Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT02724579
Collaborator
National Cancer Institute (NCI) (NIH)
45
Enrollment
193
Locations
1
Arm
91.9
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, 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. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To estimate the progression-free survival (PFS) of children >= 3 years of age with wingless-type MMTV integration site family (WNT)-driven average-risk medulloblastoma using reduced craniospinal radiotherapy (CSI) (18 Gray [Gy]) with a limited target volume boost to the tumor bed of 36 Gy for a total of 54 Gy and reduced chemotherapy approach (no vincristine [vincristine sulfate] during radiotherapy and reduced-dose maintenance chemotherapy) and to monitor the PFS for early evidence that the outcome is unacceptable.
SECONDARY OBJECTIVES:

  1. To prospectively test the hypothesis that deoxyribonucleic acid (DNA) methylation profiling will accurately classify WNT-driven medulloblastoma.

  2. To prospectively evaluate and longitudinally model the cognitive, social, emotional, behavioral, and quality of life (QoL) functioning of children who are treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced chemotherapy (reduced cisplatin, vincristine, and lomustine [CCNU]).

EXPLORATORY OBJECTIVES:

  1. To explore whether DNA methylation profiling of medulloblastoma samples will result in a predictive classification scheme for the Sonic Hedgehog (SHH), Group 3, and Group 4 medulloblastoma subgroups according to the Heidelberg classifier. This will be addressed in a separate biology protocol.

  2. To describe the audiologic and endocrinologic toxicities, as well as peripheral neuropathy, in children treated with reduced CSI (18 Gy) with a limited target volume boost to the tumor bed (to a total of 54 Gy) and reduced cisplatin and vincristine chemotherapy.

OUTLINE:

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks.

MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine orally (PO) on day 1, vincristine sulfate intravenously (IV) over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day

  1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Actual Study Start Date :
Oct 2, 2017
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (reduced radiation therapy and chemotherapy)

RADIATION THERAPY: Beginning 4-5 weeks after surgery, patients undergo craniospinal radiation therapy 5 days a week for 6 weeks. MAINTENANCE THERAPY (WEEKS 1, 3, 5, and 7): Beginning 4-6 weeks after completion of radiation therapy patients receive lomustine PO on day 1, vincristine sulfate IV over 1 minute or via minibag on days 1, 8, and 15, and cisplatin IV over 6 hours on day 1. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY (WEEKS 2, 4, AND 6): Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 2, mesna IV over 15-30 minutes on days 1 and 2, and vincristine sulfate IV over 1 minute or via minibag on days 1 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

    • Drug: Cyclophosphamide
    Given IV
    Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • Cyclophosphamide Monohydrate
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Lomustine
    Given PO
    Other Names:
  • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
  • Belustin
  • Belustine
  • CCNU
  • Cecenu
  • CeeNU
  • Chloroethylcyclohexylnitrosourea
  • Citostal
  • Gleostine
  • Lomeblastin
  • Lomustinum
  • Lucostin
  • Lucostine
  • N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
  • Prava
  • RB-1509
  • WR-139017

    • Radiation: Radiation Therapy
    Undergo craniospinal radiation therapy
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

    • Drug: Vincristine
    Given IV or via minibag
    Other Names:
  • Leurocristine
  • VCR
  • Vincrystine

    • Drug: Vincristine Sulfate
    Given IV or via minibag
    Other Names:
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfate
  • Oncovin
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristine, sulfate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) [From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 10 years]

      PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. PFS will also be reported based on central radiology review.

    Secondary Outcome Measures

    1. Deoxyribonucleic acid (DNA) methylation profiling as real-time classification of WNT-driven medulloblastoma [Within 32 days of definitive surgery]

      Results will be compared to the results of the molecular screening tests. The sensitivity and specificity comparison between DNA methylation arrays and the standard methods (molecular screening tests for WNT using immunohistochemistry [IHC] and CTNNB1 sequencing) will be performed using McNemar's test.

    2. Change in neurocognitive function (cognitive, social, emotional and behavioral) according to Children Oncology Group Standard Neuropsychological Battery [Baseline to up to 60 months post-diagnosis]

      Neurocognitive function will be measured at 9, 30 and 60 months post diagnosis and will be compared with the neurocognitive outcomes from an age and gender matched ACNS0331 cohort to the WNT patients treated on ACNS1422. Data for all assessments will be available as standardized t-scores. The change over time for each component of the neuropsychological testing will be estimated using the Generalized Estimating Equation (GEE) approach, with the standardized t-scores as the dependent variable and the assessment times as a covariate. Within the ACNS1422 cohort GEE models will also be used to explore associations of changes over time with factors such as gender, age at initiation of radiation therapy, tumor location, number of surgical interventions, etc.

    Other Outcome Measures

    1. DNA methylation profiling of medulloblastoma real-time" predictive classification scheme for the SHH, group 3 and group 4 medulloblastoma subgroups according to the Heidelberg classifier [Within 32 days of definitive surgery]

      The proportion of patients classified into each medulloblastoma subgroup will be reported.

    2. Audiologic and endocrinologic toxicities [Up to 10 years]

      The proportions of children who experienced audiologic, endocrinologic, and peripheral neuropathy toxicities per grade will be estimated along with 95% confidence interval based on an exact binomial distribution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must be newly diagnosed and have:

    • Eligibility confirmed by rapid central pathology and molecular screening review on APEC14B1:

    • Classical histologic type (non LC/A) WNT medulloblastoma

    • Positive nuclear beta-catenin by immunohistochemistry (IHC)

    • Positive for CTNNB1 mutation

    • Negative for MYC and MYCN by fluorescence in situ hybridization (FISH)

    • Patient must have negative lumbar cerebrospinal fluid (CSF) cytology

    • Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status; patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated; patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively

    • Patients must have eligibility confirmed by Rapid Central Imaging Review on APEC14B1; patients must have =< 1.5 cm^2 maximal cross-sectional area of residual tumor; whole brain magnetic resonance imaging (MRI) with and without gadolinium and spine MRI with gadolinium must be performed

    • Patients must be enrolled, and protocol therapy must be projected to begin, no later than 36 days after definitive diagnostic surgery (day 0)

    • Peripheral absolute neutrophil count (ANC) >= 1000/uL

    • Platelet count >= 100,000/uL (transfusion independent)

    • Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)

    • 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:

    • 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and females)

    • 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)

    • 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)

    • 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL (females)

    • = 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL (females)

    • The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)

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

    • Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (3x ULN); for the purpose of this study, the ULN for SGPT is 45 U/L

    • Central nervous system function defined as:

    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled

    • Patients must not be in status epilepticus, a coma or on assisted ventilation at the time of study enrollment

    • Patients must have receptive and expressive language skills in English, French, or Spanish to complete the QoL and neurocognitive assessments; if a patient meets these criteria but the parent/guardian speaks a language other than English, French, or Spanish, the patient may still be enrolled and tested, and the parent-report measures should be omitted

    • All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

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

    Exclusion Criteria:

    • Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible

    • Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids

    • Pregnancy and Breast Feeding

    • Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies

    • 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

    • Patients with a history of moderate to profound intellectual disability (i.e., intelligence quotient [Q)]=< 55) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g., dyslexia) are eligible for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 USA Health Strada Patient Care Center Mobile Alabama United States 36604
    3 Providence Alaska Medical Center Anchorage Alaska United States 99508
    4 Banner Children's at Desert Mesa Arizona United States 85202
    5 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    6 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
    7 Kaiser Permanente Downey Medical Center Downey California United States 90242
    8 Loma Linda University Medical Center Loma Linda California United States 92354
    9 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    10 Children's Hospital Los Angeles Los Angeles California United States 90027
    11 Cedars Sinai Medical Center Los Angeles California United States 90048
    12 Mattel Children's Hospital UCLA Los Angeles California United States 90095
    13 Valley Children's Hospital Madera California United States 93636
    14 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    15 Kaiser Permanente-Oakland Oakland California United States 94611
    16 Children's Hospital of Orange County Orange California United States 92868
    17 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
    18 Sutter Medical Center Sacramento Sacramento California United States 95816
    19 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    20 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    21 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    22 Children's Hospital Colorado Aurora Colorado United States 80045
    23 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado United States 80218
    24 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    25 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    26 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    27 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    28 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    29 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    30 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    31 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    32 Nicklaus Children's Hospital Miami Florida United States 33155
    33 AdventHealth Orlando Orlando Florida United States 32803
    34 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    35 Nemours Children's Hospital Orlando Florida United States 32827
    36 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    37 Sacred Heart Hospital Pensacola Florida United States 32504
    38 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    39 Tampa General Hospital Tampa Florida United States 33606
    40 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    41 Saint Mary's Hospital West Palm Beach Florida United States 33407
    42 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    43 Memorial Health University Medical Center Savannah Georgia United States 31404
    44 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    45 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    46 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
    47 University of Illinois Chicago Illinois United States 60612
    48 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    49 Loyola University Medical Center Maywood Illinois United States 60153
    50 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
    51 Advocate Children's Hospital-Park Ridge Park Ridge Illinois United States 60068
    52 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    53 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    54 Riley Hospital for Children Indianapolis Indiana United States 46202
    55 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    56 Blank Children's Hospital Des Moines Iowa United States 50309
    57 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    58 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    59 Norton Children's Hospital Louisville Kentucky United States 40202
    60 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    61 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    62 Eastern Maine Medical Center Bangor Maine United States 04401
    63 Maine Children's Cancer Program Scarborough Maine United States 04074
    64 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    65 Tufts Children's Hospital Boston Massachusetts United States 02111
    66 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    67 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    68 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    69 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    70 Children's Hospital of Michigan Detroit Michigan United States 48201
    71 Ascension Saint John Hospital Detroit Michigan United States 48236
    72 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    73 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    74 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    75 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    76 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    77 Beaumont Children's Hospital-Royal Oak Royal Oak Michigan United States 48073
    78 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    79 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    80 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    81 University of Mississippi Medical Center Jackson Mississippi United States 39216
    82 Columbia Regional Columbia Missouri United States 65201
    83 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    84 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    85 Washington University School of Medicine Saint Louis Missouri United States 63110
    86 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    87 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    88 University of Nebraska Medical Center Omaha Nebraska United States 68198
    89 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    90 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    91 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    92 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    93 Renown Regional Medical Center Reno Nevada United States 89502
    94 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    95 Hackensack University Medical Center Hackensack New Jersey United States 07601
    96 Morristown Medical Center Morristown New Jersey United States 07960
    97 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    98 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    99 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    100 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
    101 Albany Medical Center Albany New York United States 12208
    102 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    103 Roswell Park Cancer Institute Buffalo New York United States 14263
    104 NYU Winthrop Hospital Mineola New York United States 11501
    105 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    106 Mount Sinai Hospital New York New York United States 10029
    107 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    108 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    109 University of Rochester Rochester New York United States 14642
    110 Stony Brook University Medical Center Stony Brook New York United States 11794
    111 State University of New York Upstate Medical University Syracuse New York United States 13210
    112 New York Medical College Valhalla New York United States 10595
    113 Mission Hospital Asheville North Carolina United States 28801
    114 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    115 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    116 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    117 East Carolina University Greenville North Carolina United States 27834
    118 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    119 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    120 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    121 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    122 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    123 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    124 Nationwide Children's Hospital Columbus Ohio United States 43205
    125 Dayton Children's Hospital Dayton Ohio United States 45404
    126 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    127 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    128 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    129 Oregon Health and Science University Portland Oregon United States 97239
    130 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    131 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    132 Geisinger Medical Center Danville Pennsylvania United States 17822
    133 Penn State Children's Hospital Hershey Pennsylvania United States 17033
    134 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    135 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    136 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    137 Rhode Island Hospital Providence Rhode Island United States 02903
    138 Medical University of South Carolina Charleston South Carolina United States 29425
    139 Prisma Health Richland Hospital Columbia South Carolina United States 29203
    140 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    141 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    142 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    143 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    144 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
    145 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    146 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    147 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    148 Medical City Dallas Hospital Dallas Texas United States 75230
    149 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    150 El Paso Children's Hospital El Paso Texas United States 79905
    151 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    152 Covenant Children's Hospital Lubbock Texas United States 79410
    153 UMC Cancer Center / UMC Health System Lubbock Texas United States 79415
    154 Children's Hospital of San Antonio San Antonio Texas United States 78207
    155 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    156 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    157 Scott and White Memorial Hospital Temple Texas United States 76508
    158 Primary Children's Hospital Salt Lake City Utah United States 84113
    159 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    160 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    161 Inova Fairfax Hospital Falls Church Virginia United States 22042
    162 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    163 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    164 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    165 Carilion Children's Roanoke Virginia United States 24014
    166 Seattle Children's Hospital Seattle Washington United States 98105
    167 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    168 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    169 Madigan Army Medical Center Tacoma Washington United States 98431
    170 West Virginia University Healthcare Morgantown West Virginia United States 26506
    171 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    172 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    173 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    174 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    175 John Hunter Children's Hospital Hunter Regional Mail Centre New South Wales Australia 2310
    176 Women's and Children's Hospital-Adelaide North Adelaide South Australia Australia 5006
    177 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
    178 Perth Children's Hospital Perth Western Australia Australia 6009
    179 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    180 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    181 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    182 Janeway Child Health Centre Saint John's Newfoundland and Labrador Canada A1B 3V6
    183 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    184 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
    185 Kingston Health Sciences Centre Kingston Ontario Canada K7L 2V7
    186 Children's Hospital London Ontario Canada N6A 5W9
    187 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    188 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    189 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
    190 Jim Pattison Children's Hospital Saskatoon Saskatchewan Canada S7N 0W8
    191 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
    192 HIMA San Pablo Oncologic Hospital Caguas Puerto Rico 00726
    193 King Faisal Specialist Hospital and Research Centre Riyadh Saudi Arabia 11211

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Nicholas J Gottardo, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02724579
    Other Study ID Numbers:
    • ACNS1422
    • NCI-2016-00150
    • ACNS1422
    • ACNS1422
    • ACNS1422
    • U10CA180886
    First Posted:
    Mar 31, 2016
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Medulloblastoma
    Cyclophosphamide
    Lomustine
    Cisplatin
    Vincristine

    Study Results

    No Results Posted as of Aug 18, 2022