AzTrials
AzTrials

Central Nervous System Nongerminomatous Germ Cell TumorPhase 2NCT04684368

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

A Phase 2 study testing Biospecimen Collection, Carboplatin and Etoposide in people with Central Nervous System Nongerminomatous Germ Cell Tumor and Choriocarcinoma, run by Children's Oncology Group at 170 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). Read more about this study

Who is it for?
Ages 3 to 29 years
What is being tested?
Biospecimen Collection, Carboplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
170 sitesin 4 countries
Study dates
13 Jul 2021to 21 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must be >= 3 years and < 30 years at the time of study enrollment
  • Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded
  • Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
  • 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 brain MRI with and without gadolinium. Note: The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy - Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI following definitive surgery that must be obtained within 31 days prior to enrollment)
  • Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy - Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI following definitive surgery that must be obtained within 31 days prior to enrollment)
  • Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. Note: False positive cytology can occur within 10 days of surgery. If lumbar CSF for cytology is not performed prior to surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. Patients with negative CSF cytology from lumbar puncture obtained 1 to 10 days after surgery do not need cytology repeated
Show all 32Show fewer
  • Patients must have RAPID CENTRAL TUMOR MARKER REVIEW 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
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to enrollment)
  • Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to enrollment)
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex as follows (within 7 days prior to enrollment):
  • Age: Maximum serum creatinine (mg/dL)
  • 3 to < 6 years: 0.8 (male), 0.8 (female)
  • 6 to < 10 years: 1 (male), 1 (female)
  • 10 to < 13 years: 1.2 (male), 1.2 (female)
  • 13 to < 16 years: 1.5 (male), 1.4 (female)
  • >= 16 years: male (1.7), 1.4 (female)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment)
  • Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  • Central nervous system function defined as:
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
  • Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.
  • 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
  • NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:
  • English-, Spanish-, or French- speaking
  • Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments
  • No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate
  • Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery
  • Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires

Who cannot join

  • Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
  • Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
  • Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
  • Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
  • Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs
  • Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Trial locations and contacts

170 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

170 sites in 4 countries

United States152 sites, 142 recruiting

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

    Site Public Contact, 330-543-3193

    Erin Wright

    Recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Site Public Contact, 518-262-5513

    Lauren R. Weintraub

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Jacob A. Troutman

    Recruiting

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org

    Brenda J. Wittman

    Recruiting

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125

    Andrea T. Franson

    Recruiting

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, 30329

    Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org

    Jason R. Fangusaro

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org

    Holly B. Lindsay

    Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org

    Shannon M. Cohn

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Site Public Contact, 410-601-9083

    Jason M. Fixler

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Kenneth J. Cohen

    Recruiting

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

    Site Public Contact, 207-973-4274

    Daniel L. Callaway

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

    Suspended

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Martha M. Pacheco

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    Laura Wiltsie

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Kee Kiat Yeo

    Recruiting

  • Maimonides Medical Center

    Brooklyn, New York, 11219

    Site Public Contact, 718-765-2500

    Mahmut Y. Celiker

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Clare J. Twist

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Jessica L. Heath

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Jacqueline M. Kraveka

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Joel A. Kaplan

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Brian C. Belyea

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Alicia Lenzen

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Dipti S. Dighe

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Wendy S. Darlington

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Site Public Contact, 513-636-2799, cancer@cchmc.org

    Trent R. Hummel

    Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

    Site Public Contact, 216-844-5437

    Duncan S. Stearns

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Active, not recruiting

  • University of Missouri Children's Hospital

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-1960, snwq62@health.missouri.edu

    Barbara A. Gruner

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Stuart L. Cramer

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org

    Mark A. Ranalli

    Recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

    Site Public Contact, 361-694-5311, Crystal.DeLosSantos@dchstx.org

    Nkechi I. Mba

    Recruiting

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

    Site Public Contact, 972-566-5588

    Maurizio L. Ghisoli

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Daniel C. Bowers, 214-648-3896, Daniel.Bowers@utsouthwestern.edu

    Daniel C. Bowers

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Jagadeesh Ramdas

    Recruiting

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

    Site Public Contact, 800-228-4055

    Jordan M. Wright

    Recruiting

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-8912, samantha.mallory@unitypoint.org

    Samantha L. Mallory

    Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Stephanie A. Toll

    Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

    Site Public Contact, 626-564-3455

    Hung N. Tran

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Jessica M. Sun

    Recruiting

  • Michigan State University

    East Lansing, Michigan, 48823

    Active, not recruiting

  • El Paso Children's Hospital

    El Paso, Texas, 79905

    Site Public Contact, 915-298-5444, ranjan.bista@ttuhsc.edu

    Benjamin Carcamo

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Samuel J. Milanovich

    Recruiting

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

    Site Public Contact, 239-343-5333, molly.arnstrom@leehealth.org

    Emad K. Salman

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org

    Sibo Zhao

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010, cancer-center@ufl.edu

    Brian Stover

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Andrea R. Whitfield

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 551-996-2897

    Derek R. Hanson

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Site Public Contact, 860-545-9981

    Michael S. Isakoff

    Recruiting

  • Oncology Las Vegas - Henderson

    Henderson, Nevada, 89074

    Suspended

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

    Site Public Contact, 717-531-6012

    Lisa M. McGregor

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

    Site Public Contact, 808-983-6090

    Wade T. Kyono

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Jack M. Su

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Najat C. Daw, 713-792-6315, ndaw@mdanderson.org

    Najat C. Daw

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Sandeep Batra, 317-944-8784, batras@iu.edu

    Sandeep Batra

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Andrew P. Groves

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    Amanda Strobel

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

    Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu

    Keith J. August

    Recruiting

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916

    Site Public Contact, 865-541-8266

    Susan E. Spiller

    Recruiting

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

    Suspended

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Angela Ricci

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    James T. Badgett

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    Michael W. Bishop

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Site Public Contact, 909-558-4050

    Albert Kheradpour

    Recruiting

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

    Site Public Contact, 562-933-5600

    Jacqueline N. Casillas

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Site Public Contact, 323-361-4110

    Tom B. Davidson

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Hung N. Tran

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Fataneh (Fae) Majlessipour

    Recruiting

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

    Site Public Contact, 502-629-5500, CancerResource@nortonhealthcare.org

    Michael J. Ferguson

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Site Public Contact, 559-353-3000, Research@valleychildrens.org

    Ruetima Titapiwatanakun

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Nicholas J. Pytel

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Nicholas J. Pytel

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Suspended

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Eugene Suh

    Recruiting

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Site Public Contact, 888-226-4343, referralinfo@stjude.org

    Aditi Bagchi

    Recruiting

  • Banner Children's at Desert

    Mesa, Arizona, 85202

    Site Public Contact, 480-412-3100

    Joseph C. Torkildson

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Bradley Gampel

    Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

    Site Public Contact, 888-624-2778

    Ziad A. Khatib

    Recruiting

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

    Site Public Contact, 612-813-5913, pauline.mitby@childrensmn.org

    Michael K. Richards

    Recruiting

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Ashley E. Meyer

    Recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Site Public Contact, 973-971-5900

    Kathryn L. Laurie

    Recruiting

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

    Site Public Contact, 615-342-1919

    Clinton M. Carroll

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Adam J. Esbenshade

    Recruiting

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

    Site Public Contact, 732-745-8600 ext. 6163, kcovert@saintpetersuh.com

    Nibal A. Zaghloul

    Recruiting

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-8675

    Nehal S. Parikh

    Recruiting

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Asher M. Marks

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Asher M. Marks

    Recruiting

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040

    Site Public Contact, 718-470-3460

    Mark P. Atlas

    Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org

    Craig Lotterman

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Elizabeth A. Raetz

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Sameer Farouk Sait

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Site Public Contact, 973-926-7230, Christine.Kosmides@rwjbh.org

    Nehal S. Parikh

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

    Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org

    Melissa S. Mark

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Aarati V. Rao

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Rene Y. McNall-Knapp

    Recruiting

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114

    Site Public Contact, 402-955-3949

    Jill C. Beck

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Jill C. Beck

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868

    Site Public Contact, 714-509-8646, oncresearch@choc.org

    Elyssa M. Rubin

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

    Site Public Contact, 321-841-5357, Jennifer.spinelli@orlandohealth.com

    Zhongbo Hu

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

    Site Public Contact, 800-694-0012, ccto-office@stanford.edu

    Jay Michael S. Balagtas

    Recruiting

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

    Site Public Contact, 973-754-2207, HallL@sjhmc.org

    Alissa Kahn

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Jeffrey H. Schwartz

    Recruiting

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

    Suspended

  • OSF Children's Hospital of Illinois

    Peoria, Illinois, 61637

    Site Public Contact, 309-624-4945, ChildrensHospitalofIllinois@osfhealthcare.org

    Prerna Kumar

    Recruiting

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

    Site Public Contact, 215-427-8991

    Gregory E. Halligan

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

    Site Public Contact, 602-546-0920

    Michael R. Mangum

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-692-8570, jean.tersak@chp.edu

    James T. Felker

    Recruiting

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

    Site Public Contact, 503-413-2560

    Jason M. Glover

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Neha J. Patel

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Site Public Contact, 401-444-1488

    Bradley DeNardo

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Site Public Contact, 775-982-5050, Renown-CRD@renown.org

    Alan K. Ikeda

    Recruiting

  • Cancer Care Specialists - Reno

    Reno, Nevada, 89511

    Suspended

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Active, not recruiting

  • Carilion Children's

    Roanoke, Virginia, 24014

    Site Public Contact, 540-266-6238, wpmccarty@carilionclinic.org

    Erwood G. Edwards

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Joseph Z. Wilson

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    David N. Korones

    Recruiting

  • Corewell Health Children's

    Royal Oak, Michigan, 48073

    Site Public Contact, 248-551-7695

    Marie V. Nelson

    Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

    Site Public Contact, 801-585-5270

    Priya Chan

    Recruiting

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207

    Site Public Contact, 210-704-2894, bridget.medina@christushealth.org

    Julie Voeller

    Recruiting

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

    Site Public Contact, 210-575-6240, Vinod.GidvaniDiaz@hcahealthcare.com

    Jose M. Esquilin

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Site Public Contact, 210-450-3800, phoresearchoffice@uthscsa.edu

    Shafqat Shah

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

    Site Public Contact, 858-966-5934

    William D. Roberts

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Alyssa T. Reddy

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Stanley Chaleff

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Site Public Contact, 866-987-2000

    Sarah E. Leary

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Kayelyn J. Wagner

    Recruiting

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

    Site Public Contact, 800-228-6618, HopeBeginsHere@providence.org

    Judy L. Felgenhauer

    Recruiting

  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

    Site Public Contact, 314-268-4000

    William S. Ferguson

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Mohamed S. Abdelbaki

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Robin D. Hanson

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Site Public Contact, 727-767-4784, Ashley.Repp@jhmi.edu

    Stacie L. Stapleton

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Laura E. Hogan

    Recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jamie L. Dargart

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Site Public Contact, 315-464-5476

    Melanie A. Comito

    Recruiting

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

    Site Public Contact, 253-403-1461, research@multicare.org

    Robert G. Irwin

    Recruiting

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

    Site Public Contact, 253-968-6144, melissa.a.forouhar.mil@health.mil

    Melissa A. Forouhar

    Recruiting

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

    Site Public Contact, 813-357-0849, jennifer.manns@baycare.org

    Don E. Eslin

    Recruiting

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

    Site Public Contact, 254-724-5407

    Nicholas W. McGregor

    Recruiting

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Alice Lee

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Alice Lee

    Recruiting

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jamie L. Dargart

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Monica M. Davini

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Suspended

  • New York Medical College

    Valhalla, New York, 10595

    Site Public Contact, 914-594-3794

    Andrew J. Bellantoni

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org

    Jeffrey S. Dome

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Sarah Supples

    Recruiting

Other trials in United States

Canada11 sites, 11 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Site Public Contact, 403-220-6898, research4kids@ucalgary.ca

    Victor A. Lewis

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Site Public Contact, 780-407-8798, pedsoncologyresearch@ahs.ca

    Sarah J. McKillop

    Recruiting

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

    Site Public Contact, 902-470-8520, Research@iwk.nshealth.ca

    Chelsea Ash

    Recruiting

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

    Site Public Contact, 905-521-2100

    Uma H. Athale

    Recruiting

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

    Site Public Contact, 514-412-4445, info@thechildren.com

    Stephanie Mourad

    Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca

    Monia Marzouki

    Recruiting

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Québec, G1V 4G2

    Site Public Contact, 418-525-4444, rechclinique@crchudequebec.ulaval.ca

    Bruno Michon

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca

    Stephanie Vairy

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Site Public Contact, 416-813-7654, ask.CRS@sickkids.ca

    Pak Yin Anthony Liu

    Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

    Site Public Contact, 604-875-2345 ext. 6477

    Rebecca J. Deyell

    Recruiting

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

    Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca

    Stephanie M. Villeneuve

    Recruiting

Other trials in Canada

Australia6 sites, 6 recruiting

  • Women's and Children's Hospital-Adelaide

    North Adelaide, South Australia, 5006

    Site Public Contact, (08) 8161 7327, cywhs.oncsec@health.sa.gov.au

    Maria L. Kirby

    Recruiting

  • Royal Children's Hospital

    Parkville, Victoria, 3052

    Site Public Contact, 61 3 9345 5656, Jordan.Hansford@rch.org.au

    Martin A. Campbell

    Recruiting

  • Perth Children's Hospital

    Perth, Western Australia, 6009

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Michelle Ng

    Recruiting

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

    Site Public Contact, (02) 9382-1721

    David S. Ziegler

    Recruiting

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101

    Site Public Contact, 61 7 3068 1111

    Steven A. Foresto

    Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

    Site Public Contact, 61-2-9845 1400

    Bhavna Padhye

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Christchurch Hospital

    Christchurch, 8011

    Site Public Contact, 03 364 0640

    Andrew J. Dodgshun

    Recruiting

Other trials in New Zealand

About this study

Official title: A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, 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 or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122 (NCT00047320).

II. To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123 (NCT01602666).

SECONDARY OBJECTIVES:

  1. To estimate the response rates to induction chemotherapy and WVSCI for localized NGGCT patients who achieve a CR/PR.

II. To estimate the PFS and overall survival (OS) for localized NGGCT patients who achieve a CR/PR and receive WVSCI.

III. To estimate the PFS and OS for patients with less than a CR/PR following Induction who subsequently receive high-dose chemotherapy with peripheral stem cell rescue (HDCSCR).

IV. To estimate the response rate for patients with less than a CR/PR following Induction who subsequently receive HDCSCR.

EXPLORATORY OBJECTIVES:

  1. To prospectively compare outcomes based on radiation modality, photon versus proton, including cognitive, social and behavioral functioning, auditory, and neuro-endocrine function.

II. To compare spinal column growth and cell counts following radiation as measured by height and weight, and complete blood count (CBC) values during and after radiation therapy, based on treatment modality (photon versus [vs.] proton therapy) and planned inclusion/exclusion of the vertebral body in patients < 13 years of age.

III. To compare local vs. central review recommendations for second-look surgery and document barriers for performing such surgeries as well as their clinical benefit in pediatric NGGCT.

IV. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults with localized CNS NGGCT with testing as per the Children's Oncology Group (COG) Standardized Neuropsychological and Behavioral Battery.

  1. To evaluate patterns of disease recurrence/failure with respect to radiation dose distribution.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of cycles 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide IV over 60-120 minutes on days 1-5 of cycles 2, 4, and 6. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients are assigned to 1 of 2 plans (ventricular + spinal canal irradiation [WVSCI] or high-dose chemotherapy with peripheral stem cell rescue [HDCSCR]) based on response to induction chemotherapy:

  • Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI. Patients who achieve radiographic CR without marker normalization proceed to HDCSCR.
  • Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated). If second-look surgery reveals mature teratoma or non-viable tumor, proceed to WVSCI. If second-look surgery reveals viable tumor, proceed to HDCSCR. Patients who are unable to undergo second-look surgery are removed from protocol therapy but remain on study for follow-up.
  • Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.
  • Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.

PLAN A (WVSCI THERAPY): Within 6 weeks of the end of induction chemotherapy or second-look surgery, patients undergo WVSCI once daily (QD) for 5 days weekly (17 fractions followed by a boost dose for 13 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.

PLAN B (CONSOLIDATION THERAPY [HDCSCR]): Within 6-9 weeks of the end of induction chemotherapy or second-look surgery, patients receive etoposide IV and thiotepa IV over 3 hours on days -5 to -3 and undergo peripheral blood stem cell (PBSC) transplant on day 0. Patients then undergo radiation therapy QD for 5 days weekly (20 fractions followed by a boost dose for 10 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients also undergo magnetic resonance imaging (MRI), as well as collection of cerebral spinal fluid (CSF) and blood sample throughout the trial.

After completion of study treatment, patients are followed for up to 10 years.

Being tested
Biospecimen Collection, Carboplatin, Etoposide, Filgrastim, Ifosfamide
Medical subject headings
Choriocarcinoma, Carcinoma, Embryonal, Teratoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of CSF and blood samples

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • FilgrastimBiological

    Also called Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi

    Given subcutaneously (SC) or IV

  • IfosfamideDrug

    Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MesnaDrug

    Also called 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna

    Given IV or orally

  • PegfilgrastimBiological

    Also called Cegfila, Dulastin, Dyrupeg, Filgrastim SD-01

    Given SC

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation, PBSCT, Peripheral Blood, Peripheral Blood Progenitor Cell Transplantation

    Undergo PBSC transplant

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo WVSCI radiation therapy

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo Craniospinal radiation therapy

  • Second-Look SurgeryProcedure or surgery

    Also called Reoperation, Repeat Surgery, Second Look, Surgical Revision

    Undergo second-look surgery if needed

  • ThiotepaDrug

    Also called 1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa

    Given IV

Study groups in NCT04684368
Study groupRoleWhat they receive
Plan A (chemotherapy, WVSCI, second-look surgery if needed)ExperimentalSee Outline in Detailed Description.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Procedure: Magnetic Resonance Imaging; Drug: Mesna; Biological: Pegfilgrastim; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Second-Look Surgery
Plan B (chemotherapy, HDCSCR, second-look surgery if needed)ExperimentalSee Outline in Detailed Description.
Receives: Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Procedure: Magnetic Resonance Imaging; Drug: Mesna; Biological: Pegfilgrastim; Procedure: Peripheral Blood Stem Cell Transplantation; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Second-Look Surgery; Drug: Thiotepa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure rate

    Will be measured by the number of progressions or deaths within 2 years of enrollment for the cohort treated with whole ventricular + spinal canal irradiation (WVSCI). The final analysis will include an exact binomial confidence interval of the failure rate for each of the failure types (local, distant/spinal or both) without adjustment for multiplicity.

    Measured: Within 2 years of enrollment

  2. Spinal failure rate

    Will be measured by the number of spinal relapses (spine alone or distant relapses including the spine) within 2 years of enrollment in patients treated with WVSCI. The final analysis will include an exact binomial confidence interval of spinal failure rate.

    Measured: Within 2 years of enrollment

Secondary outcomes (5)

  1. Radiographic complete response (CR)/partial response (PR) with marker normalization rate post induction/second-look surgery

    Will be assessed in patients treated with induction chemotherapy. Will be estimated using an exact binomial approach and its confidence interval.

    Measured: Approximately 6 to 9 months post-treatment initiation

  2. Radiographic complete response (CR)/partial response (PR) with marker normalization rate post high-dose chemotherapy with peripheral stem cell rescue (HDCSCR)

    Will be assessed in patients treated with HDCSCR. Will be estimated using an exact binomial approach and its confidence interval.

    Measured: Up to 2 years post-treatment initiation

  3. Progression-free survival (PFS)

    Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based PFS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the primary analyses.

    Measured: From enrollment until disease progression or death from any cause for patients with events, and until final follow up for those who are event free at the time of analysis, assessed up to 10 years

  4. Overall survival (OS)

    Will be estimated separately for those treated with WVSCI and with HDCSCR + radiation therapy. Kaplan-Maier based OS curve estimates will be included, where patients who are lost to follow up will be treated as censored observations as part of the secondary analyses.

    Measured: From enrollment until death from any cause for patients with events and until final follow up for those who are alive at the time of analysis, assessed up to 10 years

  5. Patterns of disease recurrence/failure

    Will be analyzed in an exploratory manner with respect to radiation dose distribution.

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start13 Jul 2021
  3. Primary completion21 Dec 2029 (estimated)
  4. Study completion21 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684368
Sponsor's protocol ID
ACNS2021
Other IDs
NCI-2020-13175, ACNS2021, ACNS2021, U10CA180886
Status last verified
Sep 2026
First submitted
15 Dec 2020
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Carboplatin and Etoposide in people with Central Nervous System Nongerminomatous Germ Cell Tumor and Choriocarcinoma, run by Children's Oncology Group at 170 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure rate (time frame: Within 2 years of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04684368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in