Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01602666 : Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
PhasePhase 2
AgesMin: 3 Years Max: 21 Years
Eligibility
Inclusion 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 hCG? > 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 hCG? 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 hCG? 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 hCG? ? 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 hCG? ? 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/?L

- Platelet count ? 100,000/?L (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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01602666      |      Link to official Clinicaltrials.gov listing
Locations
Randwick, New South Wales
Australia

Facility: Sydney Children's Hospital
Investigator: Draga Barbaric
Contact: Draga Barbaric Phone: (02) 9382-1721
Email not avaialable

Sydney, New South Wales
Australia

Facility: The Children's Hospital at Westmead
Investigator: Geoffrey B. McCowage
Contact: Geoffrey B. McCowage Phone: 61-2-9845 1400
Email not avaialable

Herston, Queensland
Australia

Facility: Royal Childrens Hospital
Investigator: Helen Irving
Contact: Helen Irving Phone: 888-823-5923
Click HERE to send email to this center

Perth, Western Australia
Australia

Facility: Princess Margaret Hospital for Children
Investigator: Catherine H. Cole
Contact: Catherine H. Cole Phone: (08) 9340 8330
Click HERE to send email to this center

Vancouver, British Columbia
Canada

Facility: British Columbia Children's Hospital
Investigator: Caron Strahlendorf
Contact: Caron Strahlendorf Phone: 604-875-2345ext6477
Email not avaialable

Winnipeg, Manitoba
Canada

Facility: CancerCare Manitoba
Investigator: Rochelle A. Yanofsky
Contact: Rochelle A. Yanofsky Phone: 866-561-1026
Click HERE to send email to this center

Halifax, Nova Scotia
Canada

Facility: IWK Health Centre
Investigator: Margaret C. Yhap
Contact: Margaret C. Yhap Phone: 902-470-8394
Email not avaialable

Hamilton, Ontario
Canada

Facility: McMaster Children's Hospital at Hamilton Health Sciences
Investigator: Carol Portwine
Contact: Carol Portwine Phone: 905-521-2100ext74595
Email not avaialable

Toronto, Ontario
Canada

Facility: Hospital for Sick Children
Investigator: Ute K. Bartels
Contact: Ute K. Bartels Phone: 416-813-7654ext2027
Click HERE to send email to this center

Montreal, Quebec
Canada

Facility: Hospital Sainte-Justine
Investigator: Yvan Samson
Contact: Yvan Samson Phone: 514-345-4931
Email not avaialable

Birmingham, Alabama
Facility: Children's Hospital of Alabama
Investigator: Alyssa T. Reddy
Contact: Alyssa T. Reddy Phone: 205-934-0309
Email not avaialable

Birmingham, Alabama
Facility: University of Alabama at Birmingham
Investigator: Alyssa T. Reddy
Contact: Alyssa T. Reddy Phone: 205-934-0309
Email not avaialable

Long Beach, California
Facility: Miller Children's Hospital
Investigator: Amanda M. Termuhlen
Contact: Amanda M. Termuhlen Phone: 562-933-5437
Email not avaialable

Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Leo Mascarenhas
Contact: Leo Mascarenhas Phone: 323-361-4110
Email not avaialable

Oakland, California
Facility: Children's Hospital and Research Center at Oakland
Investigator: Joseph C. Torkildson
Contact: Joseph C. Torkildson Phone: 510-450-7600
Email not avaialable

Orange, California
Facility: Childrens Hospital of Orange County
Investigator: Violet Shen
Contact: Violet Shen Phone: 714-997-3000
Email not avaialable

Palo Alto, California
Facility: Lucile Packard Children's Hospital Stanford University
Investigator: Neyssa M. Marina
Contact: Neyssa M. Marina Phone: 650-498-7061
Click HERE to send email to this center

San Francisco, California
Facility: University of California San Francisco Medical Center-Parnassus
Investigator: Anuradha Banerjee
Contact: Anuradha Banerjee Phone: 877-827-3222
Email not avaialable

Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator: Michael S. Isakoff
Contact: Michael S. Isakoff Phone: 860-545-9981
Email not avaialable

New Haven, Connecticut
Facility: Yale University
Investigator: Nina S. Kadan-Lottick
Contact: Nina S. Kadan-Lottick Phone: 203-785-5702
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Jeffrey S. Dome
Contact: Jeffrey S. Dome Phone: 202-884-2549
Email not avaialable

Fort Myers, Florida
Facility: Lee Memorial Health System
Investigator: Emad K. Salman
Contact: Emad K. Salman Phone: 239-343-5333
Email not avaialable

Gainesville, Florida
Facility: University of Florida
Investigator: William B. Slayton
Contact: William B. Slayton Phone: 352-273-8675
Click HERE to send email to this center

Orlando, Florida
Facility: M D Anderson Cancer Center- Orlando
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-841-7246
Email not avaialable

Orlando, Florida
Facility: Florida Hospital
Investigator: Clifford A. Selsky
Contact: Clifford A. Selsky Phone: 407-303-5623
Email not avaialable

Saint Petersburg, Florida
Facility: All Children's Hospital
Investigator: Gregory A. Hale
Contact: Gregory A. Hale Phone: 727-767-4176
Email not avaialable

Atlanta, Georgia
Facility: Children's Healthcare of Atlanta - Egleston
Investigator: Howard M. Katzenstein
Contact: Howard M. Katzenstein Phone: 888-785-1112
Email not avaialable

Honolulu, Hawaii
Facility: University of Hawaii
Investigator: Robert W. Wilkinson
Contact: Robert W. Wilkinson Phone: 808-983-6090
Email not avaialable

Chicago, Illinois
Facility: Childrens Memorial Hospital
Investigator: Stewart Goldman
Contact: Stewart Goldman Phone: 773-880-4562
Email not avaialable

Chicago, Illinois
Facility: University of Illinois
Investigator: Mary L. Schmidt
Contact: Mary L. Schmidt Phone: 312-355-3046
Email not avaialable

Maywood, Illinois
Facility: Loyola University Medical Center
Investigator: Ricarchito B. Manera
Contact: Ricarchito B. Manera Phone: 708-226-4357
Email not avaialable

Peoria, Illinois
Facility: Saint Jude Midwest Affiliate
Investigator: Pedro A. De Alarcon
Contact: Pedro A. De Alarcon Phone: 309-655-3258
Email not avaialable

Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: Robert J. Fallon
Contact: Robert J. Fallon Phone: 317-274-2552
Email not avaialable

Indianapolis, Indiana
Facility: Saint Vincent Hospital and Health Services
Investigator: Bassem I. Razzouk
Contact: Bassem I. Razzouk Phone: 317-338-2194
Email not avaialable

Des Moines, Iowa
Facility: Raymond Blank Children's Hospital
Investigator: Wendy L. Woods-Swafford
Contact: Wendy L. Woods-Swafford Phone: 888-823-5923
Click HERE to send email to this center

Lexington, Kentucky
Facility: University of Kentucky
Investigator: Martha F. Greenwood
Contact: Martha F. Greenwood Phone: 859-257-3379
Email not avaialable

Louisville, Kentucky
Facility: Kosair Children's Hospital
Investigator: Salvatore J. Bertolone
Contact: Salvatore J. Bertolone Phone: 866-530-5516
Email not avaialable

New Orleans, Louisiana
Facility: Children's Hospital-Main Campus
Investigator: Lolie C. Yu
Contact: Lolie C. Yu Phone: 504-894-5377
Email not avaialable

Baltimore, Maryland
Facility: Johns Hopkins University
Investigator: Kenneth J. Cohen
Contact: Kenneth J. Cohen Phone: 410-955-8804
Click HERE to send email to this center

Boston, Massachusetts
Facility: Dana-Farber Cancer Institute
Investigator: Carlos Rodriguez-Galindo
Contact: Carlos Rodriguez-Galindo Phone: 866-790-4500
Email not avaialable

Detroit, Michigan
Facility: Wayne State University
Investigator: Zhihong J. Wang
Contact: Zhihong J. Wang Phone: 313-576-9363
Email not avaialable

Grand Rapids, Michigan
Facility: Helen DeVos Children's Hospital at Spectrum Health
Investigator: David S. Dickens
Contact: David S. Dickens Phone: 616-267-1925
Email not avaialable

Minneapolis, Minnesota
Facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
Investigator: Bruce C. Bostrom
Contact: Bruce C. Bostrom Phone: 612-813-5193
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Amulya A. Nageswara Rao
Contact: Amulya A. Nageswara Rao Phone: 507-538-7623
Email not avaialable

Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Gail C. Megason
Contact: Gail C. Megason Phone: 601-815-6700
Email not avaialable

Kansas City, Missouri
Facility: The Childrens Mercy Hospital
Investigator: Maxine L. Hetherington
Contact: Maxine L. Hetherington Phone: 816-234-3265
Email not avaialable

Saint Louis, Missouri
Facility: Saint John's Mercy Medical Center
Investigator: Bethany G. Sleckman
Contact: Bethany G. Sleckman Phone: 913-948-5588
Email not avaialable

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Karen M. Gauvain
Contact: Karen M. Gauvain Phone: 314-268-4000
Click HERE to send email to this center

Las Vegas, Nevada
Facility: Nevada Cancer Research Foundation CCOP
Investigator: Jonathan Bernstein
Contact: Jonathan Bernstein Phone: 702-384-0013
Email not avaialable

Morristown, New Jersey
Facility: Morristown Memorial Hospital
Investigator: Steven L. Halpern
Contact: Steven L. Halpern Phone: 973-971-5900
Email not avaialable

Summit, New Jersey
Facility: Overlook Hospital
Investigator: Steven L. Halpern
Contact: Steven L. Halpern Phone: 973-971-5900
Email not avaialable

Albuquerque, New Mexico
Facility: University of New Mexico Cancer Center
Investigator: Koh B. Boayue
Contact: Koh B. Boayue Phone: 505-272-6972
Email not avaialable

Bronx, New York
Facility: Montefiore Medical Center
Investigator: Peter D. Cole
Contact: Peter D. Cole Phone: 718-904-2730
Click HERE to send email to this center

New York, New York
Facility: Memorial Sloan Kettering Cancer Center
Investigator: Ira J. Dunkel
Contact: Ira J. Dunkel Phone: 212-639-7202
Email not avaialable

New York, New York
Facility: New York University Langone Medical Center
Investigator: Jeffrey C. Allen
Contact: Jeffrey C. Allen Phone: 212-263-4434
Click HERE to send email to this center

Syracuse, New York
Facility: State University of New York Upstate Medical University
Investigator: Karol H. Kerr
Contact: Karol H. Kerr Phone: 315-464-5476
Email not avaialable

Valhalla, New York
Facility: New York Medical College
Investigator: Mehmet F. Ozkaynak
Contact: Mehmet F. Ozkaynak Phone: 914-594-3794
Email not avaialable

Chapel Hill, North Carolina
Facility: University of North Carolina
Investigator: Stuart H. Gold
Contact: Stuart H. Gold Phone: 877-668-0683
Email not avaialable

Charlotte, North Carolina
Facility: Carolinas Medical Center
Investigator: Joel A. Kaplan
Contact: Joel A. Kaplan Phone: 704-355-2884
Email not avaialable

Durham, North Carolina
Facility: Duke University Medical Center
Investigator: Susan G. Kreissman
Contact: Susan G. Kreissman Phone: 888-275-3853
Email not avaialable

Akron, Ohio
Facility: Children's Hospital Medical Center of Akron
Investigator: Steven J. Kuerbitz
Contact: Steven J. Kuerbitz Phone: 330-543-3193
Email not avaialable

Cincinnati, Ohio
Facility: Cincinnati Children's Hospital Medical Center
Investigator: John P. Perentesis
Contact: John P. Perentesis Phone: 513-636-2799
Email not avaialable

Cleveland, Ohio
Facility: Rainbow Babies and Childrens Hospital
Investigator: Yousif (Joe) H. Matloub
Contact: Yousif (Joe) H. Matloub Phone: 216-844-5437
Email not avaialable

Columbus, Ohio
Facility: Nationwide Children's Hospital
Investigator: Mark A. Ranalli
Contact: Mark A. Ranalli Phone: 614-722-2708
Email not avaialable

Dayton, Ohio
Facility: The Children's Medical Center of Dayton
Investigator: Emmett H. Broxson
Contact: Emmett H. Broxson Phone: 800-228-4055
Email not avaialable

Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-4272
Click HERE to send email to this center

Portland, Oregon
Facility: Legacy Emanuel Children's Hospital
Investigator: Janice F. Olson
Contact: Janice F. Olson Phone: 503-413-2560
Email not avaialable

Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Kellie J. Nazemi
Contact: Kellie J. Nazemi Phone: 503-494-1080
Click HERE to send email to this center

Hershey, Pennsylvania
Facility: Penn State Hershey Children's Hospital
Investigator: Lisa M. McGregor
Contact: Lisa M. McGregor Phone: 717-531-6012
Email not avaialable

Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator: Michael J. Fisher
Contact: Michael J. Fisher Phone: 215-590-2810
Email not avaialable

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Arthur K. Ritchey
Contact: Arthur K. Ritchey Phone: 412-692-5573
Email not avaialable

Columbia, South Carolina
Facility: Palmetto Health Richland
Investigator: Ronnie W. Neuberg
Contact: Ronnie W. Neuberg Phone: 803-434-3680
Email not avaialable

Greenville, South Carolina
Facility: BI-LO Charities Children's Cancer Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant Phone: 864-241-6251
Email not avaialable

Greenville, South Carolina
Facility: Greenville Cancer Treatment Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant Phone: 864-241-6251
Email not avaialable

Sioux Falls, South Dakota
Facility: Sanford USD Medical Center - Sioux Falls
Investigator: Kayelyn J. Wagner
Contact: Kayelyn J. Wagner Phone: 605-328-1367
Email not avaialable

Knoxville, Tennessee
Facility: East Tennessee Childrens Hospital
Investigator: Ray C. Pais
Contact: Ray C. Pais Phone: 865-541-8266
Email not avaialable

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Wayne L. Furman
Contact: Wayne L. Furman Phone: 901-595-4644
Email not avaialable

Nashville, Tennessee
Facility: Vanderbilt-Ingram Cancer Center
Investigator: Adam Esbenshade
Contact: Adam Esbenshade Phone: 800-811-8480
Email not avaialable

Corpus Christi, Texas
Facility: Driscoll Children's Hospital
Investigator: M. C. Johnson
Contact: M. C. Johnson Phone: 361-694-5311
Email not avaialable

Dallas, Texas
Facility: University of Texas Southwestern Medical Center
Investigator: Naomi J. Winick
Contact: Naomi J. Winick Phone: 214-648-7097
Email not avaialable

Fort Worth, Texas
Facility: Cook Children's Medical Center
Investigator: Mary Meaghan P. Granger
Contact: Mary Meaghan P. Granger Phone: 682-885-2103
Email not avaialable

Houston, Texas
Facility: Baylor College of Medicine
Investigator: Lisa R. Bomgaars
Contact: Lisa R. Bomgaars Phone: 713-798-1354
Click HERE to send email to this center

Salt Lake City, Utah
Facility: Primary Children's Medical Center
Investigator: Phillip E. Barnette
Contact: Phillip E. Barnette Phone: 801-585-5270
Email not avaialable

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Sarah Leary
Contact: Sarah Leary Phone: 866-987-2000
Email not avaialable

Milwaukee, Wisconsin
Facility: Midwest Children's Cancer Center
Investigator: Michael E. Kelly
Contact: Michael E. Kelly Phone: 414-805-4380
Email not avaialable




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