Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma

Sponsor
Children's Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01096368
Collaborator
National Cancer Institute (NCI) (NIH)
477
209
3
154.7
2.3
0

Study Details

Study Description

Brief Summary

This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy (vincristine, cisplatin, etoposide and cyclophosphamide [VCEC]).
EXPLORATORY OBJECTIVES:
  1. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC).

  2. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection OR children who achieve a CR to short course induction chemotherapy following first surgery.

  3. To evaluate whether the addition of maintenance chemotherapy post-radiation therapy contributes to neurobehavioral morbidity and reduced functional outcomes over time, compared to patients treated with radiation therapy followed by observation alone.

  4. To examine differences in neurobehavioral outcomes and quality of life of children treated with proton beam radiation therapy compared to children treated with conventional radiation delivery techniques.

  5. To evaluate biologic prognostic factors in childhood ependymoma by studying molecular groups as defined by deoxyribonucleic acid (DNA) methylation profiling and immunohistochemistry, copy number variants to identify 1q gain in posterior fossa ependymomas, CDKN2A loss (homozygous deletion) in supratentorial ependymomas and specific genetic alterations such as RELA fusions, YAP1 fusions and the H3 K27M mutation on initial tumor samples and correlating these data with clinical outcome.

Va. To explore prognostic molecular signatures and genomic alterations in ependymomas by building upon the data derived from ACNS0121 to correlate biomarkers listed above with World Health Organization (WHO) grade, location, extent of resection, treatment, EFS and OS.

OUTLINE: Patients are assigned to Arm I or randomized to Arms II or III.

Arm I: Patients receive vincristine intravenously (IV) over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response are randomized to Arm II or III. Patients achieving stable disease, partial response, or locally progressive disease and who are deemed potentially resectable undergo surgery within 15 days after completion of induction chemotherapy. Patients with sub total resection are assigned to Arm II. Patients with gross total resection undergo observation.

ARM II: Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients undergo conformal radiotherapy over 6-7 weeks and then undergo observation.

After completion of study therapy, patients are followed up every 4 months for 5 years, and then annually thereafter.

Study Design

Study Type:
Interventional
Actual Enrollment :
477 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years
Actual Study Start Date :
Mar 29, 2010
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Feb 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (radiotherapy, chemotherapy)

Patients receive vincristine IV over 1 minute on days 1 and 8 of cycles 1 and 2, carboplatin IV over 15-60 minutes on day 1 of cycles 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of cycle 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of cycle 2 only. Cycle 1 continues for 3 weeks and cycle 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • 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
  • Drug: Etoposide
    Given IV
    Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • Other: Laboratory Biomarker Analysis
    Optional correlative studies

    Drug: Vincristine
    Given IV
    Other Names:
  • Leurocristine
  • VCR
  • Vincrystine
  • Experimental: Arm II (radiotherapy, chemotherapy)

    Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine IV on days 1, 8, and 15 of cycles 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

    Radiation: 3-Dimensional Conformal Radiation Therapy
    Patients undergo conformal radiotherapy
    Other Names:
  • 3-dimensional radiation therapy
  • 3D Conformal
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
  • Radiation, 3D Conformal
  • 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
  • Drug: Etoposide
    Given IV
    Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • Other: Laboratory Biomarker Analysis
    Optional correlative studies

    Drug: Vincristine
    Given IV
    Other Names:
  • Leurocristine
  • VCR
  • Vincrystine
  • Active Comparator: Arm III (radiotherapy, observation)

    Patients undergo conformal radiotherapy over 6-7 weeks and then undergo observation.

    Radiation: 3-Dimensional Conformal Radiation Therapy
    Patients undergo conformal radiotherapy
    Other Names:
  • 3-dimensional radiation therapy
  • 3D Conformal
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
  • Radiation, 3D Conformal
  • Other: Clinical Observation
    Patients undergo observation
    Other Names:
  • observation
  • Other: Laboratory Biomarker Analysis
    Optional correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Event-free survival (EFS) [From first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 5 years]

      Using Kaplan-Meier curves to estimate the observed EFS for the two randomization arms (post-radiation maintenance arm and post-radiation observation only arm). Log rank tests will be used to compare the observed EFS between the two randomization arms. Stratified log rank test will also be performed to examine the treatment difference with consideration and adjustment for the randomization groups. If outcome data on ACNS0121 or this study suggest a difference or a different pattern in outcome between the 2 randomization strata, the primary analyses will be supplemented with log-rank tests performed separately in each stratum in order not to confound the overall conclusions of the study with respect to the effect of maintenance therapy.

    2. Overall survival (OS) [From the time of randomization to death, assessed up to 5 years]

      Using Kaplan-Meier curves to estimate the observed OS for the two randomization arms (post-radiation Maintenance arm and post-radiation Observation only arm). Log rank tests will be used to compare the observed OS between the two randomization arms. Stratified log rank test will also be performed to examine the treatment difference with consideration and adjustment for the randomization groups. If outcome data on ACNS0121 or this study suggest a difference or a different pattern in outcome between the 2 randomization strata, the primary analyses will be supplemented with log-rank tests performed separately in each stratum in order not to confound the overall conclusions of the study with respect to the effect of maintenance therapy.

    Secondary Outcome Measures

    1. Event free survival (EFS) of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery [Up to 5 years]

      Kaplan-Meier curves will be used to estimate the EFS for patients who were non-randomly assigned to receive maintenance chemotherapy after incomplete resection

    2. Overall survival (OS) of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery [Up to 5 years]

      Kaplan-Meier curves will be used to estimate the OS for patients who were non-randomly assigned to receive maintenance chemotherapy after incomplete resection

    3. Event free survival (EFS) of children with supratentorial classic ependymoma who achieve complete resection at first or second surgery or children who achieve complete response (CR) after induction chemo assigned to observation [Up to 5 years]

      Estimated using Kaplan-Meier curves for patients with supratentorial classic disease that achieve complete resection or CR to induction chemotherapy and are assigned to observation only.

    4. Overall survival (OS) of children with supratentorial classic ependymoma who achieve complete resection at first or second surgery or children who achieve complete response (CR) after induction chemo assigned to observation [Up to 5 years]

      Estimated using Kaplan-Meier curves for patients with supratentorial classic disease that achieve complete resection or CR to induction chemotherapy and are assigned to observation only.

    5. Neurologic, neuropsychological, and endocrine long-term sequelae of surgery, conformal radiotherapy, and maintenance chemotherapy [At 9, 30, and 60 months post diagnosis]

      Will be observed.

    6. Gene expression signatures and genomic alterations in pediatric ependymoma [At the time of first or second surgery]

      Will be observed.

    7. Telomere maintenance [Up to 5 years]

      Descriptive statistics will be used to summarize the various telomere maintenance measures. Log rank tests and multivariate Cox proportional hazards models will be used to explore the association between a telomere maintenance measurement and EFS/OS, with potential adjustments for the effects of other possible prognostic factors. Reliability of human telomerase reverse transcriptase (hTERT) immunohistochemistry results versus telomeric repeat amplification protocol (TRAP) assay results will be calculated using the kappa statistic.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Months to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO
    1. are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above
    • There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy

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

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

    Exclusion Criteria:
    • Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease

    • Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible

    • No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment

    • Pregnant female patients are not eligible for this study

    • Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained

    • Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

    • Lactating females may not participate unless they have agreed not to breastfeed a child while on this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    3 Banner Children's at Desert Mesa Arizona United States 85202
    4 Phoenix Childrens Hospital Phoenix Arizona United States 85016
    5 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    6 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
    7 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    8 Kaiser Permanente Downey Medical Center Downey California United States 90242
    9 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    10 Loma Linda University Medical Center Loma Linda California United States 92354
    11 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    12 Children's Hospital Los Angeles Los Angeles California United States 90027
    13 Cedars Sinai Medical Center Los Angeles California United States 90048
    14 Valley Children's Hospital Madera California United States 93636
    15 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    16 Kaiser Permanente-Oakland Oakland California United States 94611
    17 Children's Hospital of Orange County Orange California United States 92868
    18 Lucile Packard Children's Hospital Stanford University Palo Alto California United States 94304
    19 Sutter Medical Center Sacramento Sacramento California United States 95816
    20 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    21 Rady Children's Hospital - San Diego San Diego California United States 92123
    22 UCSF Medical Center-Parnassus San Francisco California United States 94143
    23 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    24 Children's Hospital Colorado Aurora Colorado United States 80045
    25 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    26 Yale University New Haven Connecticut United States 06520
    27 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    28 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    29 Children's National Medical Center Washington District of Columbia United States 20010
    30 Broward Health Medical Center Fort Lauderdale Florida United States 33316
    31 Lee Memorial Health System Fort Myers Florida United States 33901
    32 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    33 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    34 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    35 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    36 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    37 Nicklaus Children's Hospital Miami Florida United States 33155
    38 AdventHealth Orlando Orlando Florida United States 32803
    39 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    40 Nemours Children's Clinic - Orlando Orlando Florida United States 32806
    41 Orlando Health Cancer Institute Orlando Florida United States 32806
    42 Nemours Children's Hospital Orlando Florida United States 32827
    43 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    44 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    45 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    46 Saint Mary's Hospital West Palm Beach Florida United States 33407
    47 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    48 Augusta University Medical Center Augusta Georgia United States 30912
    49 Memorial Health University Medical Center Savannah Georgia United States 31404
    50 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    51 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    52 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
    53 University of Illinois Chicago Illinois United States 60612
    54 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    55 Loyola University Medical Center Maywood Illinois United States 60153
    56 Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois United States 60453
    57 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    58 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    59 Riley Hospital for Children Indianapolis Indiana United States 46202
    60 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    61 Blank Children's Hospital Des Moines Iowa United States 50309
    62 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    63 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    64 Norton Children's Hospital Louisville Kentucky United States 40202
    65 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    66 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    67 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    68 Eastern Maine Medical Center Bangor Maine United States 04401
    69 Maine Children's Cancer Program Scarborough Maine United States 04074
    70 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    71 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    72 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    73 Tufts Children's Hospital Boston Massachusetts United States 02111
    74 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    75 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    76 Baystate Medical Center Springfield Massachusetts United States 01199
    77 C S Mott Children's Hospital Ann Arbor Michigan United States 48109
    78 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    79 Ascension Saint John Hospital Detroit Michigan United States 48236
    80 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    81 Hurley Medical Center Flint Michigan United States 48503
    82 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    83 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    84 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    85 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    86 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    87 University of Mississippi Medical Center Jackson Mississippi United States 39216
    88 Columbia Regional Columbia Missouri United States 65201
    89 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    90 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    91 Washington University School of Medicine Saint Louis Missouri United States 63110
    92 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    93 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    94 University of Nebraska Medical Center Omaha Nebraska United States 68198
    95 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    96 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    97 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    98 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    99 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    100 Hackensack University Medical Center Hackensack New Jersey United States 07601
    101 Saint Barnabas Medical Center Livingston New Jersey United States 07039
    102 Morristown Medical Center Morristown New Jersey United States 07960
    103 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    104 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    105 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    106 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
    107 Overlook Hospital Summit New Jersey United States 07902
    108 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    109 Albany Medical Center Albany New York United States 12208
    110 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    111 Roswell Park Cancer Institute Buffalo New York United States 14263
    112 NYU Winthrop Hospital Mineola New York United States 11501
    113 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    114 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    115 Mount Sinai Hospital New York New York United States 10029
    116 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    117 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    118 University of Rochester Rochester New York United States 14642
    119 State University of New York Upstate Medical University Syracuse New York United States 13210
    120 New York Medical College Valhalla New York United States 10595
    121 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    122 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    123 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    124 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    125 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    126 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    127 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    128 Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106
    129 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    130 Nationwide Children's Hospital Columbus Ohio United States 43205
    131 Dayton Children's Hospital Dayton Ohio United States 45404
    132 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    133 Mercy Children's Hospital Toledo Ohio United States 43608
    134 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    135 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    136 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    137 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    138 Geisinger Medical Center Danville Pennsylvania United States 17822
    139 Penn State Children's Hospital Hershey Pennsylvania United States 17033
    140 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    141 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    142 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    143 Rhode Island Hospital Providence Rhode Island United States 02903
    144 Medical University of South Carolina Charleston South Carolina United States 29425
    145 Prisma Health Richland Hospital Columbia South Carolina United States 29203
    146 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    147 Greenville Cancer Treatment Center Greenville South Carolina United States 29605
    148 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    149 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    150 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    151 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
    152 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
    153 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    154 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    155 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    156 Medical City Dallas Hospital Dallas Texas United States 75230
    157 Cook Children's Medical Center Fort Worth Texas United States 76104
    158 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    159 Covenant Children's Hospital Lubbock Texas United States 79410
    160 UMC Cancer Center / UMC Health System Lubbock Texas United States 79415
    161 Children's Hospital of San Antonio San Antonio Texas United States 78207
    162 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    163 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    164 Scott and White Memorial Hospital Temple Texas United States 76508
    165 Primary Children's Hospital Salt Lake City Utah United States 84113
    166 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    167 Inova Fairfax Hospital Falls Church Virginia United States 22042
    168 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    169 Naval Medical Center - Portsmouth Portsmouth Virginia United States 23708-2197
    170 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    171 Carilion Children's Roanoke Virginia United States 24014
    172 Seattle Children's Hospital Seattle Washington United States 98105
    173 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    174 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    175 Madigan Army Medical Center Tacoma Washington United States 98431
    176 West Virginia University Charleston Division Charleston West Virginia United States 25304
    177 West Virginia University Healthcare Morgantown West Virginia United States 26506
    178 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    179 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    180 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    181 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    182 John Hunter Children's Hospital Hunter Regional Mail Centre New South Wales Australia 2310
    183 Sydney Children's Hospital Randwick New South Wales Australia 2031
    184 The Children's Hospital at Westmead Westmead New South Wales Australia 2145
    185 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
    186 Royal Children's Hospital-Brisbane Herston Queensland Australia 4029
    187 Queensland Children's Hospital South Brisbane Queensland Australia 4101
    188 Women's and Children's Hospital-Adelaide North Adelaide South Australia Australia 5006
    189 Monash Medical Center-Clayton Campus Clayton Victoria Australia 3168
    190 Royal Children's Hospital Parkville Victoria Australia 3052
    191 Princess Margaret Hospital for Children Perth Western Australia Australia 6008
    192 Perth Children's Hospital Perth Western Australia Australia 6009
    193 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    194 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    195 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    196 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    197 Janeway Child Health Centre Saint John's Newfoundland and Labrador Canada A1B 3V6
    198 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    199 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
    200 Kingston Health Sciences Centre Kingston Ontario Canada K7L 2V7
    201 Children's Hospital London Ontario Canada N6A 5W9
    202 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    203 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    204 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
    205 Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec Canada H3T 1C5
    206 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
    207 Centre Hospitalier Universitaire de Quebec Quebec Canada G1V 4G2
    208 Starship Children's Hospital Grafton Auckland New Zealand 1145
    209 Christchurch Hospital Christchurch New Zealand 8011

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Amy A Smith, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01096368
    Other Study ID Numbers:
    • ACNS0831
    • NCI-2011-02029
    • 10-01676
    • COG-ACNS0831
    • CDR0000668560
    • ACNS0831
    • ACNS0831
    • U10CA180886
    • U10CA098543
    First Posted:
    Mar 31, 2010
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    No Results Posted as of Mar 21, 2022