Trial record 1 of 1 for:    ACNS0334
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Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

This study is currently recruiting participants.
Verified February 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00336024
First received: June 8, 2006
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given before a peripheral stem cell transplant in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.


Condition Intervention Phase
Untreated Childhood Medulloblastoma
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor
Drug: etoposide
Drug: cyclophosphamide
Drug: cisplatin
Biological: filgrastim
Drug: carboplatin
Drug: thiotepa
Drug: methotrexate
Drug: leucovorin calcium
Drug: vincristine sulfate
Procedure: autologous hematopoietic stem cell transplantation
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children <36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue Versus the Same Therapy Without Methotrexate

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Complete response (CR) rate [ Time Frame: From baseline to up to 4 years ] [ Designated as safety issue: No ]
    The analysis of response will be based on a one-sided, two-sample test of proportions, with Type I error of 10%. Tumor response criteria are determined by changes in size using all 3 dimensional measurements: width (W), transverse (T), and length (L) measurements.


Secondary Outcome Measures:
  • Time to treatment failure defined as disease progression or recurrence, death from any cause, or occurrence of a second malignant neoplasm [ Time Frame: From baseline to up to 5 years ] [ Designated as safety issue: No ]

    The analysis of event-free survival (EFS) will be based on a proportional hazards, non-mixture parametric cure model (PCM).

    Partial stratification will be accomplished by separately estimating the scale parameter of the Weibull kernel function within each of the patient arms.


  • Toxicity rates of acute, chronic, and late effects of the two intense regimens [ Time Frame: From the beginning of treatment to end of study, assessed up to 4 years ] [ Designated as safety issue: Yes ]
    Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Patients who have progression or recurrence of disease will be censored in these analyses. Differences in incidence for treatment regimens will be tested with the log-rank test for overall pattern.

  • Rates of gastrointestinal and nutritional toxicities [ Time Frame: In each course or treatment ] [ Designated as safety issue: Yes ]
    Rates of gastrointestinal and nutritional toxicities will be summarized using standard descriptive statistical methods. The two groups will be compared using a Chi-square test to detect a significant difference in complications between the two groups.

  • Quality of life and neuropsychological (NP) scores as assessed by the Children Oncology Group (COG) Standard Neuropsychological and Behavioral Battery [ Time Frame: From baseline to up to 4 years ] [ Designated as safety issue: No ]
    Parent-report questionnaires will be completed to gather information about the patient's function, specifically in terms of attention, memory, executive abilities, and behavioral/social/emotional adaptation. Long-term effects of treatment on neuropsychological and quality of life outcomes will be primarily descriptive. Correlational analyses will be conducted, with Pearson product moment correlations computed for continuous data and chi-square analyses conducted for discrete data.

  • Gene expression profiling by northern blotting or by gel electrophoresis [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    The methods used by Golub and colleagues and Pomeroy and colleagues, as well as standard statistical techniques such as Cox regression analysis will be used in these analyses. Internal cross-validation procedures, such as the leave-one-out method, will be utilized in the training set to provide less-biased estimates of correct classification rates.


Estimated Enrollment: 96
Study Start Date: August 2007
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (induction+consolidation chemotherapy, autologous PBSC))

Patients receive vincristine sulfate IV on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3. Treatment repeats every 3 weeks for 3 courses.

Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: thiotepa
Given IV
Other Names:
  • Oncotiotepa
  • STEPA
  • TESPA
  • Tespamin
  • TSPA
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSC transplantation
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (induction+consolidation chemotherapy, autologous PBSC)

Patients receive vincristine sulfate IV on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Treatment repeats every 3 weeks for 3 courses.

Within 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and filgrastim (G-CSF) IV or SC beginning on day 54 and continuing until blood counts recover. Patients also receive autologous PBSC IV on day 4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Biological: filgrastim
Given IV or SC
Other Names:
  • G-CSF
  • Neupogen
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: thiotepa
Given IV
Other Names:
  • Oncotiotepa
  • STEPA
  • TESPA
  • Tespamin
  • TSPA
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • Folex
  • methylaminopterin
  • Mexate
  • MTX
Drug: leucovorin calcium
Given IV or orally
Other Names:
  • CF
  • CFR
  • LV
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSC transplantation
Other: laboratory biomarker analysis
Correlative studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 1 of the following:

    • High-risk medulloblastoma defined by any of the following:

      • Residual disease > 1.5 cm²
      • Lumbar cerebral spinal fluid cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or ≥ 10 days after definitive surgery unless contraindicated
      • M0 disease in children < 8 months of age at diagnosis
      • M2 or M3 metastatic disease by MRI
      • M4 disease
    • Supratentorial primitive neuroectodermal tumor (PNET)(any M-stage)
    • Anaplastic medulloblastoma regardless of M-stage or residual tumor
    • M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically measurable residual disease < 1.5 cm^2
  • MRI evidence of spinal disease
  • Tumor must be negative for INI1 gene
  • Has undergone definitive surgery within the past 31 days
  • No atypical teratoid rhabdoid tumors
  • Biological specimens must be available for correlative laboratory studies
  • Life expectancy > 8 weeks
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2 times ULN
  • Shortening fraction ≥ 27% by echocardiogram
  • Ejection fraction ≥ 47% by radionuclide angiogram
  • No evidence of dyspnea at rest
  • Pulse oximetry > 94% on room air
  • Absolute neutrophil count > 1,000/mm³
  • Platelet count > 100,000/mm³ (transfusion independent)
  • Hemoglobin > 8 g/dL (RBC transfusions allowed)
  • Prior corticosteroids allowed
  • No prior radiation therapy or chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336024

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
United States, Arizona
Phoenix Childrens Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Antranik A. Bedros    909-558-3375      
Principal Investigator: Antranik A. Bedros         
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Amanda M. Termuhlen    562-933-5437      
Principal Investigator: Amanda M. Termuhlen         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868-3874
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Sutter General Hospital Active, not recruiting
Sacramento, California, United States, 95816
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Jay Michael S. Balagtas    916-734-3089      
Principal Investigator: Jay Michael S. Balagtas         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts    858-966-5934      
Principal Investigator: William D. Roberts         
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
Contact: Anuradha Banerjee    877-827-3222      
Principal Investigator: Anuradha Banerjee         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicholas K. Foreman    720-777-6672      
Principal Investigator: Nicholas K. Foreman         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Broward Health Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hector M. Rodriguez-Cortes    954-355-5346      
Principal Investigator: Hector M. Rodriguez-Cortes         
Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: William B. Slayton    352-273-8675    trials@cancer.ufl.edu   
Principal Investigator: William B. Slayton         
Memorial Healthcare System - Joe DiMaggio Children's Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Iftikhar Hanif    954-265-2234      
Principal Investigator: Iftikhar Hanif         
Nemours Children's Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207-8426
Contact: Eric S. Sandler    904-697-3529      
Principal Investigator: Eric S. Sandler         
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Julio C. Barredo    866-574-5124    Sylvester@emergingmed.com   
Principal Investigator: Julio C. Barredo         
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon    305-662-8360      
Principal Investigator: Enrique A. Escalon         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Clifford A. Selsky    407-303-5623      
Principal Investigator: Clifford A. Selsky         
Nemours Childrens Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Ramamoorthy Nagasubramanian    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
M D Anderson Cancer Center- Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246      
Principal Investigator: Vincent F. Giusti         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423    HamblinF@allkids.org   
Principal Investigator: Gregory A. Hale         
Saint Joseph Children's Hospital of Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Hardeo K. Panchoosingh    800-882-4123      
Principal Investigator: Hardeo K. Panchoosingh         
Saint Mary's Hospital Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Narayana Gowda         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein    888-785-1112      
Principal Investigator: Howard M. Katzenstein         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: J. Martin Johnston    912-350-8568      
Principal Investigator: J. Martin Johnston         
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang    800-845-4624      
Principal Investigator: Eugenia Chang         
United States, Illinois
Childrens Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Contact: Stewart Goldman    773-880-4562      
Principal Investigator: Stewart Goldman         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Ricarchito B. Manera    708-226-4357      
Principal Investigator: Ricarchito B. Manera         
Advocate Hope Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Sharad N. Salvi    847-723-7570      
Principal Investigator: Sharad N. Salvi         
United States, Indiana
Saint Vincent Hospital and Health Services Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194      
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ayman A. El-Sheikh    800-237-1225      
Principal Investigator: Ayman A. El-Sheikh         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Martha F. Greenwood    859-257-3379      
Principal Investigator: Martha F. Greenwood         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Salvatore J. Bertolone    866-530-5516      
Principal Investigator: Salvatore J. Bertolone         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Tammuella C. Singleton    504-988-6121      
Principal Investigator: Tammuella C. Singleton         
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Judith B. Allen    207-973-4274      
Principal Investigator: Judith B. Allen         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287-8936
Contact: Kenneth J. Cohen    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Kenneth J. Cohen         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Stephen S. Roberts    212-639-7202      
Principal Investigator: Stephen S. Roberts         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo    866-790-4500      
Principal Investigator: Carlos Rodriguez-Galindo         
Floating Hospital for Children at Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Johannes E. Wolff    617-636-5000    ContactUsCancerCenter@TuftsMedicalCenter.org   
Principal Investigator: Johannes E. Wolff         
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-267-1925      
Principal Investigator: David S. Dickens         
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
Kalamazoo Center for Medical Studies Recruiting
Kalamazoo, Michigan, United States, 49008
Contact: Jeffrey S. Lobel    800-227-2345      
Principal Investigator: Jeffrey S. Lobel         
Michigan State University - Breslin Cancer Center Terminated
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
University of Minnesota Medical Center-Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Christopher L. Moertel    612-624-2620      
Principal Investigator: Christopher L. Moertel         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amulya A. Nageswara Rao    507-538-7623      
Principal Investigator: Amulya A. Nageswara Rao         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington    816-234-3265      
Principal Investigator: Maxine L. Hetherington         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Shalini Shenoy    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Shalini Shenoy         
Saint John's Mercy Medical Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Burton E. Appel    201-996-2879      
Principal Investigator: Burton E. Appel         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
UMDNJ - Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Peri Kamalakar    973-926-7230      
Principal Investigator: Peri Kamalakar         
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-2909      
Principal Investigator: Mary A. Bonilla         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467-2490
Contact: Peter D. Cole    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Peter D. Cole         
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Martin L. Brecher    877-275-7724      
Principal Investigator: Martin L. Brecher         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    866-946-8476      
Principal Investigator: Mark E. Weinblatt         
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jeffrey C. Allen    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Jeffrey C. Allen         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter G. Steinherz    212-639-7202      
Principal Investigator: Peter G. Steinherz         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Lisa R. Hackney    585-275-5830      
Principal Investigator: Lisa R. Hackney         
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mehmet F. Ozkaynak    914-594-3794      
Principal Investigator: Mehmet F. Ozkaynak         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    877-668-0683      
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Paulette C. Bryant    704-384-5369      
Principal Investigator: Paulette C. Bryant         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Tanya M. Tekautz    866-223-8100      
Principal Investigator: Tanya M. Tekautz         
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
The Children's Medical Center of Dayton Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Rama Jasty    419-251-8210      
Principal Investigator: Rama Jasty         
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Dagmar T. Stein    419-824-1842      
Principal Investigator: Dagmar T. Stein         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kellie J. Nazemi    503-494-1080    trials@ohsu.edu   
Principal Investigator: Kellie J. Nazemi         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2001
Contact: Jeffrey S. Taylor    570-271-5251      
Principal Investigator: Jeffrey S. Taylor         
Saint Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Gregory E. Halligan    215-427-8991      
Principal Investigator: Gregory E. Halligan         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael J. Fisher    215-590-2810      
Principal Investigator: Michael J. Fisher         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey    412-692-5573      
Principal Investigator: Arthur K. Ritchey         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
Principal Investigator: Ray C. Pais         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Haydar A. Frangoul    800-811-8480      
Principal Investigator: Haydar A. Frangoul         
United States, Texas
Texas Tech University Health Science Center-Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Osvaldo Regueira    806-354-5411      
Principal Investigator: Osvaldo Regueira         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky    972-566-5588      
Principal Investigator: Carl Lenarsky         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Mary Meaghan P. Granger    682-885-2103      
Principal Investigator: Mary Meaghan P. Granger         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Lisa R. Bomgaars    713-798-1354    burton@bcm.edu   
Principal Investigator: Lisa R. Bomgaars         
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan    806-725-8000    jaccresearch@covhs.org   
Principal Investigator: Latha Prasannan         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Jaime Estrada    210-575-7000      
Principal Investigator: Jaime Estrada         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Anne-Marie R. Langevin    210-567-0653    che@uthscsa.edu   
Principal Investigator: Anne-Marie R. Langevin         
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette    801-585-5270      
Principal Investigator: Phillip E. Barnette         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Alan C. Homans    802-656-8990      
Principal Investigator: Alan C. Homans         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Kamar Godder    804-628-1939      
Principal Investigator: Kamar Godder         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Jeffrey R. Geyer    866-987-2000      
Principal Investigator: Jeffrey R. Geyer         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Robert G. Irwin         
United States, Wisconsin
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Michael J. McManus    715-389-4457      
Principal Investigator: Michael J. McManus         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly    414-805-4380      
Principal Investigator: Michael E. Kelly         
Australia, New South Wales
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Draga Barbaric    (02) 9382-1721      
Principal Investigator: Draga Barbaric         
The Children's Hospital at Westmead Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage    61-2-9845 1400      
Principal Investigator: Geoffrey B. McCowage         
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud       crdo.info@mcri.edu.au   
Principal Investigator: Francoise M. Mechinaud         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    (08) 9340 8330    admin@childcancerresearch.com.au   
Principal Investigator: Catherine H. Cole         
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother    403-220-6898    research4kids@ucalgary.ca   
Principal Investigator: Douglas R. Strother         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-2345ext6477      
Principal Investigator: Caron Strahlendorf         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    866-561-1026    CIO_Web@cancercare.mb.ca   
Principal Investigator: Rochelle A. Yanofsky         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap    902-470-8394      
Principal Investigator: Margaret C. Yhap         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
Chedoke-McMaster Hospitals Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Carol Portwine    905-521-2100ext74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M. Halton    613-738-3931      
Principal Investigator: Jacqueline M. Halton         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ronald M. Grant    416-813-7654ext2027    jason.mcguire@sickkids.ca   
Principal Investigator: Ronald M. Grant         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4445    info@thechildren.com   
Principal Investigator: Sharon B. Abish         
Hospital Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Centre Hospitalier Universitaire de Quebec Recruiting
Ste-Foy, Quebec, Canada, G1V 4G2
Contact: Bruno Michon    418-525-4444      
Principal Investigator: Bruno Michon         
Puerto Rico
San Jorge Children's Hospital Recruiting
Santurce, Puerto Rico, 00912
Contact: Luis A. Clavell    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Luis A. Clavell         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Claire Mazewski Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00336024     History of Changes
Other Study ID Numbers: ACNS0334, NCI-2009-00338, COG-ACNS0334, CDR0000483683, U10CA098543
Study First Received: June 8, 2006
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Etoposide phosphate
Cisplatin
Cyclophosphamide
Etoposide
Methotrexate
Thiotepa
Vincristine
Carboplatin
Lenograstim
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on April 22, 2014