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Trial record 1 of 1 for:    COG ACNS0831
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Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma

This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01096368
First received: March 30, 2010
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

RATIONALE: 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 or by stopping them from dividing. 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.

PURPOSE: This 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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
 Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: vincristine sulfate
Other: clinical observation
Radiation: 3-dimensional conformal radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival (EFS) [ Designated as safety issue: No ]
  • Overall survival (OS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Neurologic, neuropsychological, and endocrine long-term sequelae of surgery, conformal radiotherapy, and maintenance chemotherapy comprising vincristine sulfate, cisplatin, etoposide, and cyclophosphamide as compared to those patients treated on COG- ... [ Designated as safety issue: No ]
  • Gene expression signatures and genomic alterations in pediatric ependymoma [ Designated as safety issue: No ]
  • Prognostic molecular signatures and genomic alterations in ependymomas [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2010
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine sulfate IV on days 1, 8, and 15 (courses 1-3 only); etoposide IV over 1-2 hours on days 1-3; cisplatin IV over 1-8 hours on day 1; and cyclophosphamide IV over 30-60 minutes on days 1-2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
 Drug: cisplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: vincristine sulfate
Given IV
Radiation: 3-dimensional conformal radiation therapy
Patients undergo conformal radiotherapy
Active Comparator: Arm II
Patients undergo conformal radiotherapy over 6-7 weeks.
 Other: clinical observation
Patients undergo observation
Radiation: 3-dimensional conformal radiation therapy
Patients undergo conformal radiotherapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine the event-free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with maintenance chemotherapy comprising vincristine sulfate, cisplatin, etoposide, and cyclophosphamide (VCEC) versus observation following post-operative conformal radiotherapy (cRT).

Secondary

  • 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 are non-randomly assigned to cRT followed by VCEC.
  • 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.
  • To determine the neurologic, neuropsychological, and endocrine long-term sequelae of surgery, cRT, and VCEC as compared to those patients treated on COG-ACNS0121.
  • To determine biologic prognostic factors in childhood ependymoma by utilizing genomic profiles via comparative genomic hybridization and single-nucleotide polymorphism arrays, and microarray gene expression profiling analysis on initial tumor samples and correlating this with clinical outcome.
  • To evaluate prognostic immune-function gene expression in ependymomas.
  • To build upon the data derived from COG-ACNS0121 to develop genotypically based classification signatures and to correlate these to WHO grade, location, extent of resection, treatment, EFS, and OS.
  • To evaluate telomere maintenance as a prognostic marker.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of resection at initial surgery (total vs near total resection), tumor histology, and tumor location (infratentorial primary tumor vs supratentorial anaplastic tumor). Patients are randomized to 1 of 2 treatment arms. Patients with supratentorial classic tumor are assigned to arm II.

All patients receive induction chemotherapy comprising vincristine sulfate IV on days 1 and 8, carboplatin IV over 15-60 minutes on day 1, and cyclophosphamide IV over 30-60 minutes on days 1-2. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of course 2 only. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. 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.

  • Arm I: Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine sulfate IV on days 1, 8, and 15 (courses 1-3 only); etoposide IV over 1-2 hours on days 1-3; cisplatin IV over 1-8 hours on day 1; and cyclophosphamide IV over 30-60 minutes on days 1-2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo conformal radiotherapy over 6-7 weeks. Some patients undergo blood and tissue sample collection before treatment and after surgery for gene expression microarray, genomic hybridization array, and other correlative studies.

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

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial ependymoma meeting the following criteria:

    • Newly diagnosed disease

    • Classic ependymoma (WHO II) or anaplastic ependymoma (WHO III), including the following subtypes:

      • Clear cell
      • Papillary
      • Cellular
      • Combination of the above
  • No diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma

  • Has undergone surgical resection of the primary tumor

    • More than 1 attempted resection allowed

  • No metastatic disease by MRI or cerebrospinal fluid (CSF) cytology

    • CSR cytology from a ventriculostomy or permanent VP shunt that reveals the presence of tumor cells is indicative of metastatic disease

  • No evidence of non-contiguous spread beyond the primary site as determined by pre- or post-operative MRI of brain, pre- or post-operative MRI of the spine, and post-operative CSF cytology obtained from the lumbar CSF space

    • Lumbar CSF examination may be waived if deemed to be medically contraindicated

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2

    • Karnofsky PS for patients > 16 years of age
    • Lansky PS for patients ≤ 16 years of age
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent)

  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min 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) or 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 3 times ULN for patients with Gilbert syndrome or hemolytic anemia)
  • AST or ALT < 3 times ULN

  • Adequate cardiac function defined as 1 of the following:

    • Shortening fraction ≥ 27% by ECHO
    • Ejection fraction ≥ 50% by gated radionuclide study.

  • Not pregnant or nursing

    • Patients who agree to stop nursing while on this study are allowed
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior treatment for ependymoma other than surgical intervention and corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096368

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama at University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Joseph G. Pressey     205-939-9285        
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni     501-686-8274        
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut     909-558-3375        
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Recruiting
Long Beach, California, United States, 90801
Contact: Amanda M. Termuhlen     562-933-8605        
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Robert M. Cooper     323-783-5307        
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048-1865
Contact: Fataneh (Fae) Majlessipour     310-423-4423        
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas     323-361-2529        
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Children's Hospital and Research Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trial Office - Children's Hospital and Research Cente     510-450-7600        
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen     714-532-8636        
Lucile Packard Children's Hospital at Stanford University Medical Center Recruiting
Palo Alto, California, United States, 95798
Contact: Neyssa M. Marina     650-723-5535        
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego     858-966-5934        
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
United States, Colorado
Children's Hospital Colorado Center for Cancer and Blood Disorders Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly W. Maloney     720-777-6673        
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Clinical Trials Office - Connecticut Children's Medical Center     860-545-9967        
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center     203-785-5702        
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre     302-651-5755        
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Clinical Trials Office - Children's National Medical Center     202-884-2549        
United States, Florida
Broward General Medical Center Cancer Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Clinical Trials Office - Broward General Medical Center Cancer     954-355-5346        
Lee Cancer Care of Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt     877-680-0008        
University of Florida Shands Cancer Center Recruiting
Gainesville, Florida, United States, 32610-0232
Contact: Clinical Trials Office - University of Florida Shands Cancer C     888-254-7581        
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Clinical Trials Office - Memorial Cancer Institute     954-985-3443        
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric S. Sandler     904-697-3793        
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti     321-841-8588        
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute     407-303-5623        
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Ramamoorthy Nagasubramanian     407-650-7230        
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz     850-505-4790        
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale     727-767-4176        
St. Joseph's Cancer Institute at St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute     800-882-4123        
Kaplan Cancer Center at St. Mary's Medical Center Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda     561-844-6363        
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Recruiting
Atlanta, Georgia, United States, 30322
Contact: Todd M. Cooper     404-785-1838        
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang     208-381-2731        
United States, Illinois
Children's Memorial Hospital - Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Stewart Goldman     312-227-4844        
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Simmons Cooper Cancer Institute Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute     217-545-7929        
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: James M. Croop     317-944-8784        
St. Vincent Indianapolis Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital     317-338-2194        
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - Blank Children's Hospital     515-241-6729        
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital     502-629-5500     CancerResource@nortonhealthcare.org    
United States, Louisiana
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Clinical Trials Office - Children's Hospital of New Orleans     504-894-5377        
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit     800-888-8823        
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Della L. Howell     210-916-7727        
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 2115
Contact: Carlos Rodriguez-Galindo     617-632-4580        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital     800-865-1125        
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
Breslin Cancer Center at Ingham Regional Medical Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio     517-334-2765        
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M     612-813-5193        
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason     601-984-5220        
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington     816-234-3265        
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J     314-251-6770        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi     314-454-2041        
United States, Nebraska
Children's Hospital Recruiting
Omaha, Nebraska, United States, 68114-4113
Contact: Minnie Abromowitch     402-955-3950        
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ     800-999-5465        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein     702-732-1493        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
St. Barnabas Medical Center Cancer Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce     973-322-2470        
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center     973-926-3136        
St. Joseph's Hospital and Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla     973-754-3349        
Carol G. Simon Cancer Center at Morristown Memorial Hospital Recruiting
Summit, New Jersey, United States, 07901
Contact: Steven L. Halpern     973-971-6720        
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe     718-904-2730     aecc@aecom.yu.edu    
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
Schneider Children's Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene S. Redner     718-470-3460        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Peter G. Steinherz     212-639-7951        
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Linda Granowetter     212-263-8400        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina     585-275-2981        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mehmet F. Ozkaynak     914-493-7997        
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente     877-668-0683; 919-966-4432        
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Clinical Trials Office - Akron Children's Hospital     330-543-3193        
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-2799        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Yousif (Joe) H. Matloub     216-844-3345        
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Laura T. Martin     614-722-3582        
Dayton Children's - Dayton Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett H. Broxson     937-641-3111        
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Rama Jasty     419-251-8215        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp     405-271-5311        
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital     503-413-2560        
United States, Pennsylvania
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Lisa M. McGregor     717-531-6012        
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Fox     267-425-3010        
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134-1095
Contact: Clinical Trials Office - St. Christopher's Hospital for Childr     215-427-8991        
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-7056        
United States, South Carolina
Palmetto Health South Carolina Cancer Center Recruiting
Columbia, South Carolina, United States, 29203
Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer     803-434-3680        
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant     864-455-8898        
United States, Tennessee
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais     865-541-8266        
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinical Trials Office - St. Jude Children's Research Hospital     901-595-4644        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Clinical Trials Office - Dell Children's Medical Center of Cen     512-324-8022        
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Clinical Trials Office - Driscoll Children's Hospital     361-694-5311        
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky     972-566-6647x4439        
Cook Children's Medical Center - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Clinical Trials Office - Cook's Children's Medical Center     682-885-2103        
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030-2399
Contact: Patrick A. Thompson     832-824-4029        
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229-3993
Contact: Jaime Estrada     210-575-7268        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Anne-Marie R. Langevin     210-567-7477        
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Phillip E. Barnette     801-662-4700        
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe     757-668-7243        
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
Carilion Medical Center for Children at Roanoke Community Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson     540-981-7376        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Julie R. Park     206-987-2106        
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy L. Felgenhauer     509-474-2777        
Mary Bridge Children's Hospital and Health Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin     253-403-3481        
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25302
Contact: Allen R. Chauvenet     304-388-1552        
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly     414-456-4170        
Australia, New South Wales
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Draga Barbaric     612-9382-2970        
Children's Hospital at Westmead Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey B. McCowage     61298452122        
Australia, Queensland
Royal Children's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Helen Irving     617-3636-8671        
Australia, South Australia
Women's and Children's Hospital Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby     61881617411        
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud     613-9345-4893        
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine H. Cole     011-6189340-8238        
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother     403-955-7272        
Canada, British Columbia
Children's and Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf     604-875-3576        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky     204-787-4163        
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap     902-470-8778        
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine     905-521-2100x73464        
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva     613-5496666x3833        
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel     416-813-7795        
Canada, Quebec
Hopital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson     514-345-4931x2790        
Montreal Children's Hospital at McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish     514-412-4400x22219        
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Mpofu     306-655-2744        
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon     418-656-4141X47191        
New Zealand
Starship Children's Health Recruiting
Auckland, New Zealand, 1
Contact: Lochie R. Teague     649-307-4949x22423        
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amy A. Smith, MD University of Florida
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01096368     History of Changes
Other Study ID Numbers: CDR0000668560, COG-ACNS0831
Study First Received: March 30, 2010
Last Updated: November 13, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma

Additional relevant MeSH terms:
Ependymoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Cisplatin
 Cyclophosphamide
Etoposide
Vincristine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 22, 2013