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

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Status: Temporarily Closed to Accrual

Description

This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). 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, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors 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 hCGbeta > 100 mIU/mL or any elevation of serum and/or 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 hCGbeta 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 both serum and CSF markers obtained (unless obtaining CSF is medically contraindicated) and must have one of the following criteria to be eligible: ** Patients with institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) AND hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically contraindicated) (only 1 is required to be elevated) are eligible; no histologic confirmation required ** Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible; no histologic confirmation required ** Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible
  • All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment; if surgical resection is performed, patients must have pre-operative and post-operative cranial MRI with and without gadolinium; the post-operative brain MRI should be obtained within 72 hours of surgery; if patient has a biopsy only, post-operative cranial MRI is recommended but not required; all patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the spine study is performed for the first time after surgical resection or biopsy, it is recommended to be obtained with and without gadolinium
  • Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at this time, then it should be performed at least 10 days following surgery before study enrollment; false positive cytology can occur within 10 days of surgery; Note: patients with positive CSF cytology obtained prior to 10 days after surgery may have cytology repeated to determine eligibility
  • Patients must have CSF tumor markers obtained prior to enrollment unless medically contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
  • Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical diagnosis
  • Peripheral absolute neutrophil count (ANC) >= 1,000/uL
  • Platelet count >= 100,000/uL (transfusion independent)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
  • Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows: * 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) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate 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

Exclusion Criteria

  • Patients with mature teratoma or completely resected immature 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 cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible
  • Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
  • 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
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Temporarily closed to accrual
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org

Arizona

Phoenix
Phoenix Childrens Hospital
Status: Temporarily closed to accrual
Contact: Jessica Boklan
Phone: 602-546-0920

California

Downey
Southern California Permanente Medical Group
Status: Temporarily closed to accrual
Contact: Robert Michael Cooper
Phone: 626-564-3455
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Temporarily closed to accrual
Contact: Pamela Helen-Heilge Kempert Email: helpdesk@childrensoncologygroup.org
Los Angeles
Cedars Sinai Medical Center
Status: Temporarily closed to accrual
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Temporarily closed to accrual
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Mattel Children's Hospital UCLA
Status: Temporarily closed to accrual
Contact: Tom Belle Davidson Email: helpdesk@childrensoncologygroup.org
Madera
Children's Hospital Central California
Status: Temporarily closed to accrual
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Temporarily closed to accrual
Contact: Joseph Charles Torkildson Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Temporarily closed to accrual
Contact: Steven K. Bergstrom
Phone: 510-891-3400
Orange
Children's Hospital of Orange County
Status: Temporarily closed to accrual
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Temporarily closed to accrual
Contact: Sheri Lee Spunt
Phone: 650-498-7061 Email: ccto-office@stanford.edu
Sacramento
Sutter Medical Center Sacramento
Status: Temporarily closed to accrual
Contact: Yung Soon Yim
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
San Diego
Rady Children's Hospital - San Diego
Status: Temporarily closed to accrual
Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Temporarily closed to accrual
Contact: Anuradha Banerjee
Phone: 877-827-3222
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Temporarily closed to accrual
Contact: Eduard H. Panosyan
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Temporarily closed to accrual
Contact: Kathleen M. O'Toole Dorris Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Temporarily closed to accrual
Contact: Michael Scott Isakoff
Phone: 800-579-7822
New Haven
Yale University
Status: Temporarily closed to accrual
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Temporarily closed to accrual
Contact: Andrew William Walter
Phone: 302-651-5755

District of Columbia

Washington
Children's National Medical Center
Status: Temporarily closed to accrual
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org
MedStar Georgetown University Hospital
Status: Temporarily closed to accrual
Contact: Amal Mousa Abu-Ghosh
Phone: 202-444-2223

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Temporarily closed to accrual
Contact: Emad K. Salman
Phone: 877-680-0008
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Temporarily closed to accrual
Contact: Iftikhar Hanif Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Temporarily closed to accrual
Contact: Andrew William Walter
Phone: 302-651-5755
Miami
Nicklaus Children's Hospital
Status: Temporarily closed to accrual
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Temporarily closed to accrual
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Temporarily closed to accrual
Contact: Vincent Ferdinando Giusti
Phone: 321-841-7246 Email: CancerClinicalTrials@orlandohealth.com
Florida Hospital Orlando
Status: Temporarily closed to accrual
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Temporarily closed to accrual
Contact: Andrew William Walter
Phone: 302-651-5755
Pensacola
Nemours Children's Clinic - Pensacola
Status: Temporarily closed to accrual
Contact: Andrew William Walter
Phone: 302-651-5755
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Temporarily closed to accrual
Contact: Stacie Lynn Stapleton Email: helpdesk@childrensoncologygroup.org
Tampa
Tampa General Hospital
Status: Temporarily closed to accrual
Contact: Juan Felipe Rico
Phone: 813-844-8113 Email: hkourtellis@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Temporarily closed to accrual
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Temporarily closed to accrual
Contact: Tobey John MacDonald Email: helpdesk@childrensoncologygroup.org
Savannah
Memorial University Medical Center
Status: Temporarily closed to accrual
Contact: J. Martin Johnston
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Temporarily closed to accrual
Contact: Wade T. Kyono
Phone: 808-586-2979

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Eugenia Chang Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Temporarily closed to accrual
Contact: Stewart Goldman Email: helpdesk@childrensoncologygroup.org
University of Illinois
Status: Temporarily closed to accrual
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Temporarily closed to accrual
Contact: Eugene Suh
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Temporarily closed to accrual
Contact: Rebecca Erin McFall Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Temporarily closed to accrual
Contact: Caroline Yingwen Hu
Phone: 847-384-3621
Peoria
Saint Jude Midwest Affiliate
Status: Temporarily closed to accrual
Contact: Pedro A. De Alarcon
Phone: 888-226-4343

Indiana

Indianapolis
Riley Hospital for Children
Status: Temporarily closed to accrual
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Temporarily closed to accrual
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Temporarily closed to accrual
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-3305 Email: rbehrens@cancercenterofiowa.com
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Temporarily closed to accrual
Contact: Ashok B. Raj
Phone: 866-530-5516

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Temporarily closed to accrual
Contact: Lolie C. Yu Email: helpdesk@childrensoncologygroup.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Temporarily closed to accrual
Contact: Kenneth J. Cohen
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
University of Maryland / Greenebaum Cancer Center
Status: Temporarily closed to accrual
Contact: Teresa Anne York
Phone: 800-888-8823

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Contact: Susan N. Chi
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Howard Jeffrey Weinstein
Phone: 877-726-5130

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Contact: Zhihong Joanne Wang
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: Temporarily closed to accrual
Contact: Renuka Gera
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Temporarily closed to accrual
Contact: David Scott Dickens
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Temporarily closed to accrual
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Temporarily closed to accrual
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Amulya Anakapalli Nageswara Rao
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Temporarily closed to accrual
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Kansas City
The Childrens Mercy Hospital
Status: Temporarily closed to accrual
Contact: Keith Jason August
Phone: 888-823-5923 Email: ctsucontact@westat.com
Saint Louis
Mercy Hospital Saint Louis
Status: Temporarily closed to accrual
Contact: Bethany Graham Sleckman
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Temporarily closed to accrual
Contact: Karen M. Gauvain
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation CCOP
Status: Active
Contact: Jonathan Bernstein
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Temporarily closed to accrual
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Temporarily closed to accrual
Contact: Derek R. Hanson
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Temporarily closed to accrual
Contact: Steven Lon Halpern
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Temporarily closed to accrual
Contact: Richard A. Drachtman
Phone: 732-235-8675
Newark
Newark Beth Israel Medical Center
Status: Temporarily closed to accrual
Contact: Peri Kamalakar
Phone: 973-926-7230

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Temporarily closed to accrual
Contact: Koh B. Boayue
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Albany
Albany Medical Center
Status: Temporarily closed to accrual
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Lisa Gennarini
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
Buffalo
Roswell Park Cancer Institute
Status: Temporarily closed to accrual
Contact: Lorna K. Fitzpatrick
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: Temporarily closed to accrual
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Temporarily closed to accrual
Contact: Mark P. Atlas Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Temporarily closed to accrual
Contact: Alice Lee
Phone: 212-305-8615
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Temporarily closed to accrual
Contact: Sharon Leigh Gardner
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Memorial Sloan-Kettering Cancer Center
Status: Temporarily closed to accrual
Contact: Ira J. Dunkel
Phone: 212-639-7202
Rochester
University of Rochester
Status: Temporarily closed to accrual
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Temporarily closed to accrual
Contact: Philip M. Monteleone
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Temporarily closed to accrual
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Temporarily closed to accrual
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Novant Health Presbyterian Medical Center
Status: Temporarily closed to accrual
Contact: Jessica Amy Fu Bell
Phone: 704-384-5369
Durham
Duke University Medical Center
Status: Temporarily closed to accrual
Contact: Susan G. Kreissman
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: Temporarily closed to accrual
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Temporarily closed to accrual
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Temporarily closed to accrual
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Maryam Fouladi Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Temporarily closed to accrual
Contact: Aron Flagg
Phone: 866-223-8100
Columbus
Nationwide Children's Hospital
Status: Temporarily closed to accrual
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Temporarily closed to accrual
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Temporarily closed to accrual
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Temporarily closed to accrual
Contact: Janice Faye Olson
Phone: 503-413-8199
Oregon Health and Science University
Status: Temporarily closed to accrual
Contact: Kellie Jean Nazemi
Phone: 503-494-1080 Email: trials@ohsu.edu

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Temporarily closed to accrual
Contact: Lydia Alberta Boateng
Phone: 484-884-2201
Hershey
Penn State Children's Hospital
Status: Temporarily closed to accrual
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Temporarily closed to accrual
Contact: Michael J. Fisher Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Temporarily closed to accrual
Contact: Jean M. Tersak Email: helpdesk@childrensoncologygroup.org

Puerto Rico

San Juan
University Pediatric Hospital
Status: Temporarily closed to accrual
Contact: Luis A. Clavell Email: helpdesk@childrensoncologygroup.org

South Carolina

Columbia
Palmetto Health Richland
Status: Temporarily closed to accrual
Contact: Stuart Louis Cramer
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Temporarily closed to accrual
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Temporarily closed to accrual
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: Temporarily closed to accrual
Contact: Ray C. Pais
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Temporarily closed to accrual
Contact: Ibrahim Abdel-Rahim Qaddoumi Email: helpdesk@childrensoncologygroup.org
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Temporarily closed to accrual
Contact: Adam Esbenshade
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Temporarily closed to accrual
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Temporarily closed to accrual
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Temporarily closed to accrual
Contact: Daniel Charles Bowers
Phone: 214-648-7097
Fort Worth
Cook Children's Medical Center
Status: Temporarily closed to accrual
Contact: Jeffrey Carlton Murray Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Jack Meng-Fen Su
Phone: 713-798-1354 Email: burton@bcm.edu
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Contact: Soumen Khatua
Phone: 713-792-3245
San Antonio
Methodist Children's Hospital of South Texas
Status: Temporarily closed to accrual
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Temporarily closed to accrual
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Temporarily closed to accrual
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Temporarily closed to accrual
Contact: Colleen Harkins Druzgal
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Temporarily closed to accrual
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Temporarily closed to accrual
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Temporarily closed to accrual
Contact: Seth Joel Corey Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Temporarily closed to accrual
Contact: Mandy M Atkinson Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Temporarily closed to accrual
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Temporarily closed to accrual
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Temporarily closed to accrual
Contact: Melissa Anne Forouhar
Phone: 301-319-2100

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Temporarily closed to accrual
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Kenneth Brian De Santes
Phone: 800-622-8922
Milwaukee
Children's Hospital of Wisconsin
Status: Temporarily closed to accrual
Contact: Sachin S. Jogal Email: helpdesk@childrensoncologygroup.org

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Temporarily closed to accrual
Contact: David Bryan Dix Email: helpdesk@childrensoncologygroup.org

Manitoba

Winnipeg
CancerCare Manitoba
Status: Temporarily closed to accrual
Contact: Tanya Renae Brown
Phone: 306-766-2213

Nova Scotia

Halifax
IWK Health Centre
Status: Temporarily closed to accrual
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Temporarily closed to accrual
Contact: Carol Portwine Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Temporarily closed to accrual
Contact: Eric Bouffet
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Temporarily closed to accrual
Contact: Yvan Samson
Phone: 514-345-4931

Australia

Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Temporarily closed to accrual
Contact: Elizabeth Louise Hesketh Email: helpdesk@childrensoncologygroup.org
North Adelaide
Women's and Children's Hospital-Adelaide
Status: Temporarily closed to accrual
Contact: Maria Louise Kirby Email: helpdesk@childrensoncologygroup.org
Parkville
Royal Children's Hospital
Status: Temporarily closed to accrual
Contact: Jordan R. Hansford Email: helpdesk@childrensoncologygroup.org
Perth
Princess Margaret Hospital for Children
Status: Temporarily closed to accrual
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au
Randwick
Sydney Children's Hospital
Status: Temporarily closed to accrual
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org
South Brisbane
Lady Cilento Children's Hospital
Status: Temporarily closed to accrual
Contact: Helen Irving Email: helpdesk@childrensoncologygroup.org
Westmead
The Children's Hospital at Westmead
Status: Temporarily closed to accrual
Contact: Geoffrey Brian McCowage
Phone: (02) 9845 8183

New Zealand

Christchurch
Christchurch Hospital
Status: Temporarily closed to accrual
Contact: Stephen John Laughton Email: helpdesk@childrensoncologygroup.org
Grafton
Starship Children's Hospital
Status: Temporarily closed to accrual
Contact: Stephen John Laughton Email: helpdesk@childrensoncologygroup.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine, as measured by the 3-year progression-free survival (PFS) rate and patterns of failure, whether dose and volume of irradiation can be safely reduced to 30.6 Gy whole ventricular-field irradiation (WVI) plus 23.4 Gy primary site boost instead of 36 Gy craniospinal irradiation (CSI) plus primary site boost in the subgroup of children and young adults (ages 3 to =< 21 years) with localized nongerminomatous germ cell tumor (NGGCT) who have a magnetic resonance imaging (MRI) and tumor marker criteria (cerebrospinal fluid [CSF] and serum) for confirmed complete response (CR) or partial response (PR) to induction chemotherapy and negative serum and cerebrospinal fluid (CSF) tumor markers OR in patients who have less than a PR after induction chemotherapy with negative tumor markers who undergo a second-look surgery and are found to have only mature teratoma, residual scar or fibrosis and fit the definition of CR/PR after second-look surgery.

II. To determine, as measured by the 3-year PFS rate and patterns of failure, whether simplified chemotherapy followed by dose-reduced radiation therapy is effective for treating children and young adults (ages 3 to =< 21 years) with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta (hCGbeta) =< 50 mIU/mL.

III. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults who are treated with reduced radiation dose and volume of irradiation in Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum 2 (germinoma) using the ALTE07C1 protocol.

SECONDARY OBJECTIVES:

I. To estimate the PFS and overall survival (OS) distributions of patients with NGGCT treated with 30.6 Gy WVI and involved-field radiation therapy (IFR) focal boost to 54 Gy.

II. To estimate the PFS and OS distributions of localized germinoma patients who present with a) serum and/or CSF hCGbeta =< 50 mIU/mL and b) serum and/or CSF hCGbeta > 50 mIU/mL and =< 100 mIU/mL.

OUTLINE:

STRATUM I (NGGCT): Patients receive induction therapy comprising carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120 minutes 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 achieving CR or PR undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week for 6 weeks.

STRATUM II (GERMINOMA): Patients receive induction therapy comprising carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with normalization of markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4 weeks.

After completion of study treatment, patients are followed up at 3, 6, and 9 months, every 4 months for 24 months, 30 months, and then annually for up to 60 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Ute Katharina Bartels

Trial IDs

Primary ID ACNS1123
Secondary IDs NCI-2012-01967, CDR0000734032, S12-02807
Clinicaltrials.gov ID NCT01602666