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 November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00336024
First received: June 8, 2006
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

RATIONALE: 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.

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 .


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: leucovorin calcium
Drug: methotrexate
Drug: thiotepa
Drug: vincristine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response by 3-dimensional tumor measurements [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]

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: Induction therapy arm I
Patients receive vincristine 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.
Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: thiotepa
Given IV
Drug: vincristine sulfate
Given IV
Experimental: Induction therapy arm II
Patients receive vincristine 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. Once 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.
Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: leucovorin calcium
Given IV
Drug: methotrexate
Given IV
Drug: thiotepa
Given IV
Drug: vincristine sulfate
Given IV

  Show Detailed Description

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiation therapy or chemotherapy
  • Prior corticosteroids allowed
  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 at University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Joseph G. Pressey     205-939-9285        
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica Boklan     602-546-0920        
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 of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen     714-532-8636        
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Clinical Trial Office - Sutter Cancer Center     916-454-6595        
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
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        
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    
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon     305-662-8360x4960        
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        
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti     321-841-8588        
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        
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        
Keyser Family Cancer Center at Advocate Hope Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Ammar Hayani     708-684-4094        
United States, Indiana
St. Vincent Indianapolis Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital     317-338-2194        
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
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
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center     504-988-6121        
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine     207-973-4274        
United States, Maryland
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        
Floating Hospital for Children at Tufts - New England Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Johannes E.A. Wolff     617-636-5535        
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        
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Clinical Trials Office - Helen DeVos Children's Hospital     616-391-3050        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007-5381
Contact: Jeffrey S. Lobel     269-341-6350        
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        
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, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein     702-732-1493        
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        
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        
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt     516-663-9400        
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Linda Granowetter     212-263-8400        
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        
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        
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center     800-862-2215        
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        
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
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        
United States, Ohio
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        
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        
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital     419-824-1842        
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
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea     503-494-1080     trials@ohsu.edu    
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
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
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 Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Fox     267-425-3010        
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
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
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, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Tennessee
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais     865-541-8266        
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
Texas Tech University Health Sciences Center School of Medicine - Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Osvaldo Regueira     806-354-5434x282        
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        
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan     806-725-4840        
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, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
United States, Virginia
Virginia Commonwealth University Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298-0037
Contact: Clinical Trials Office -Virginia Commonwealth University Masse     804-628-1939        
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, Wisconsin
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, 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        
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M.L. Halton     613-737-7600x2370        
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
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon     418-656-4141X47191        
Puerto Rico
San Jorge Children's Hospital Recruiting
Santurce, Puerto Rico, 00912
Contact: Luis A. Clavell     787-728-1575        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Claire Mazewski, MD AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Investigator: Stewart J. Kellie, MD Children's Hospital at Westmead
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT00336024     History of Changes
Other Study ID Numbers: CDR0000483683, COG-ACNS0334
Study First Received: June 8, 2006
Last Updated: November 13, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated childhood medulloblastoma
untreated childhood supratentorial primitive neuroectodermal tumor

Additional relevant MeSH terms:
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
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
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Cisplatin
Cyclophosphamide
Etoposide
Methotrexate
Thiotepa
Vincristine
Carboplatin
Leucovorin
Levoleucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 19, 2013