Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01602666
First received: May 18, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.


Condition Intervention Phase
Childhood Central Nervous System Germ Cell Tumor
Childhood Central Nervous System Germinoma
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 3-year PFS rate with NGGCT [ Time Frame: Three years follow-up after last patient enrollment ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.

  • PFS distribution of localized CNS germinoma [ Time Frame: Three years follow-up after last patient enrollment ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.

  • Neurocognitive function using the ALTE07C1 protocol [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimation of the PFS distribution of patients with NGGCT treated with IFR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.

  • Estimation of the OS distribution of patients with NGGCT treated with IFR assessed [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.

  • Estimation of the PFS distribution of patients with localized germinoma patients and CSF serum hCGβ of 50 mIU/mL or less or CSF serum hCGβ greater than 50 mIU/mL and less than or equal to 100 mIU/mL [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.

  • Estimation of the OS distribution of patients with localized germinoma patients and CSF serum hCGβ of 50 mIU/mL or less or CSF serum hCGβ greater than 50 mIU/mL and less than or equal to 100 mIU/mL [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be provided.


Estimated Enrollment: 220
Study Start Date: May 2012
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (combination chemotherapy, radiation therapy)

Stratum 1 (NGGCT): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 1 hour and etoposide over 1-2 hours on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease (complete [CR] or partial response [PR]) to induction chemotherapy undergo radiotherapy once daily (QD) 5 days a week for 6 weeks. Patients with PR, stable disease (SD), or progressive disease (PD) and normalization of tumor levels undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo radiotherapy.

Stratum 2 (Germinoma): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3. Continued (see detailed description)

Procedure: therapeutic conventional surgery
Undergo surgery
Radiation: 3-dimensional conformal radiation therapy
Undergo 3D-CRT
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Radiation: intensity-modulated radiation therapy
Undergo IMRT
Other Name: IMRT
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213
Drug: ifosfamide
Given IV
Other Names:
  • Cyfos
  • Holoxan
  • IFF
  • IFX
  • IPP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion and Exclusion Criteria:

  • Patients must be newly diagnosed with localized primary CNS non germinomatous germ cell tumor (NGGCT) (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal +suprasellar), and ventricles are eligible; tumors present in the above mentioned locations and with unifocal parenchymal extension are eligible

    • Stratum 1( NGGCT): Patients must have one of the following criteria:

      • Patients with serum and/or CSF hCGβ > 100 mIU/mL or any elevation of serum and CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective of biopsy results
      • Patients with any of the following elements on biopsy/resection are eligible, irrespective of serum and/or CSF hCGβ and AFP levels: endodermal sinus tumor (yolk sac),embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCT with malignant GCT elements
    • Stratum 2 (Germinoma): Patients must have one of the following criteria:

      • Patients with institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum and/or CSF are eligible; no histologic confirmation required
      • Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible; no histologic confirmation required
      • Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible
  • Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless medically contraindicated
  • Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123
  • Patients with mature teratoma with normal tumor markers are not eligible
  • Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible
  • Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible
  • Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² OR serum creatinine based on age/gender as follows:

    • 0.4 mg/dL ( 1 month to < 6 months of age)
    • 0.5 mg/dL (6 months to < 1 year of age)
    • 0.6 mg/dL (1 to < 2 years of age)
    • 0.8 mg/dL (2 to < 6 years of age)
    • 1.0 mg/dL (6 to < 10 years of age)
    • 1.2 mg/dL (10 to < 13 years of age)
    • 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) and 1.4 mg/dL (female) (≥ 16 years of age)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN
  • Patients with seizure disorder may be enrolled if well controlled
  • Patients must not be in status, coma, or assisted ventilation prior to study enrollment
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
  • Patients who had more than 1 prior surgery/biopsy are eligible
  • Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602666

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
United States, California
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         
Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609-1809
Contact: Joseph C. Torkildson    510-450-7600      
Principal Investigator: Joseph C. Torkildson         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868-3874
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
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, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8032
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
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
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         
M D Anderson Cancer Center- Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7246      
Principal Investigator: Vincent F. Giusti         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Clifford A. Selsky    407-303-5623      
Principal Investigator: Clifford A. Selsky         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-4176      
Principal Investigator: Gregory A. Hale         
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         
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, Illinois
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
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         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61602
Contact: Pedro A. De Alarcon    309-655-3258      
Principal Investigator: Pedro A. De Alarcon         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
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
Raymond Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Wendy L. Woods-Swafford         
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
Children's Hospital-Main Campus Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377      
Principal Investigator: Lolie C. Yu         
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         
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         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Zhihong J. Wang    313-576-9363      
Principal Investigator: Zhihong J. Wang         
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         
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         
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: Karen M. Gauvain    314-268-4000    info@siteman.wustl.edu   
Principal Investigator: Karen M. Gauvain         
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
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
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         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ira J. Dunkel    212-639-7202      
Principal Investigator: Ira J. Dunkel         
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         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
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 Active, not recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
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         
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
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         
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012      
Principal Investigator: Lisa M. McGregor         
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
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         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    901-595-4644      
Principal Investigator: Wayne L. Furman         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Adam Esbenshade    800-811-8480      
Principal Investigator: Adam Esbenshade         
United States, Texas
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Naomi J. Winick    214-648-7097      
Principal Investigator: Naomi J. Winick         
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         
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, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Sarah Leary    866-987-2000      
Principal Investigator: Sarah Leary         
United States, Wisconsin
Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301
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, Queensland
Royal Childrens Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Helen Irving    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Helen Irving         
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, 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         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ute K. Bartels    416-813-7654ext2027    jason.mcguire@sickkids.ca   
Principal Investigator: Ute K. Bartels         
Canada, Quebec
Hospital Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Ute Bartels, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01602666     History of Changes
Other Study ID Numbers: ACNS1123, NCI-2012-01967, CDR0000734032, U10CA098543, COG-ACNS1123
Study First Received: May 18, 2012
Last Updated: October 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neurologic Manifestations
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Signs and Symptoms
Carboplatin
Etoposide
Ifosfamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014