Recruiting

Phase 2

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

Sponsor:

Children's Oncology Group

Code:

NCT04684368

Conditions

Central Nervous System Nongerminomatous Germ Cell Tumor

Choriocarcinoma

Embryonal Carcinoma

Immature Teratoma

Malignant Teratoma

Eligibility Criteria

Sex: All

Age: 3 - 29

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Carboplatin

Etoposide

Filgrastim

Ifosfamide

Study Details

Brief 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). 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.

Conditions

Central Nervous System Nongerminomatous Germ Cell Tumor

Choriocarcinoma

Embryonal Carcinoma

Immature Teratoma

Malignant Teratoma

Study ID

NCT04684368

Start date

Jul 13, 2021

Status verified date

Jan, 2026

Completion date

Dec 21, 2029

Anticipated

Primary completion date

Dec 21, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 3 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria:

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. 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 )
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)
Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
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/gender 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

Exclusion Criteria:

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Plan A (chemotherapy, WVSCI, second-look surgery if needed)

See Outline in Detailed Description.

experimental: Plan B (chemotherapy, HDCSCR, second-look surgery if needed)

See Outline in Detailed Description.

Interventions

Biospecimen Collection

Undergo collection of CSF and blood samples

Carboplatin

Given IV

Etoposide

Given IV

Filgrastim

Given subcutaneously (SC) or IV

Ifosfamide

Given IV

Magnetic Resonance Imaging

Undergo MRI

Mesna

Given IV or orally

Pegfilgrastim

Given SC

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplant

Questionnaire Administration

Ancillary studies

Radiation Therapy

Undergo WVSCI radiation therapy

Radiation Therapy

Undergo radiation therapy

Second-Look Surgery

Undergo second-look surgery if needed

Thiotepa

Given IV

Primary outcome measure

Failure rate [ Time Frame: Within 2 years of enrollment ]
Spinal failure rate [ Time Frame: Within 2 years of enrollment ]

Central Contacts and Locations

Locations

Providence Alaska Medical Center

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Site Public Contact

907-212-6871 AKPAMC.OncologyResearchSupport@providence.org

Principal Investigator:

Brenda J. Wittman

Banner Children's at Desert

Recruiting

Mesa, Arizona, United States, 85202

Contacts

Site Public Contact

480-412-3100

Principal Investigator:

Joseph C. Torkildson

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Michael R. Mangum

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Monica M. Davini

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

Michael W. Bishop

Kaiser Permanente Downey Medical Center

Recruiting

Downey, California, United States, 90242

Contacts

Site Public Contact

626-564-3455

Principal Investigator:

Hung N. Tran

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Albert Kheradpour

Miller Children's and Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

Contacts

Site Public Contact

562-933-5600

Principal Investigator:

Jacqueline N. Casillas

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

323-361-4110

Principal Investigator:

Tom B. Davidson

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

800-398-3996 clinical.trials@kp.org

Principal Investigator:

Hung N. Tran

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Site Public Contact

310-423-2133 Cancer.trial.info@cshs.org

Principal Investigator:

Fataneh (Fae) Majlessipour

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Site Public Contact

559-353-3000 Research@valleychildrens.org

Principal Investigator:

Ruetima Titapiwatanakun

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

714-509-8646 oncresearch@choc.org

Principal Investigator:

Elyssa M. Rubin

Lucile Packard Children's Hospital Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

800-694-0012 ccto-office@stanford.edu

Principal Investigator:

Jay Michael S. Balagtas

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Site Public Contact

858-966-5934

Principal Investigator:

William D. Roberts

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Site Public Contact

877-827-3222 cancertrials@ucsf.edu

Principal Investigator:

Alyssa T. Reddy

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

303-764-5056 josh.b.gordon@nsmtp.kp.org

Principal Investigator:

Holly B. Lindsay

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Site Public Contact

860-545-9981

Principal Investigator:

Michael S. Isakoff

Smilow Cancer Center/Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Asher M. Marks

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Asher M. Marks

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Sridhi Patel

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Site Public Contact

202-476-2800 OncCRC_OnCall@childrensnational.org

Principal Investigator:

Jeffrey S. Dome

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Site Public Contact

239-343-5333 molly.arnstrom@leehealth.org

Principal Investigator:

Emad K. Salman

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010 cancer-center@ufl.edu

Principal Investigator:

Brian Stover

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Sridhi Patel

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Bradley Gampel

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Public Contact

888-624-2778

Principal Investigator:

Ziad A. Khatib

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Site Public Contact

321-841-5357 Jennifer.spinelli@orlandohealth.com

Principal Investigator:

Zhongbo Hu

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Site Public Contact

302-651-5572 Allison.bruce@nemours.org

Principal Investigator:

Sridhi Patel

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Jeffrey H. Schwartz

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Site Public Contact

727-767-4784 Ashley.Repp@jhmi.edu

Principal Investigator:

Stacie L. Stapleton

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

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

813-357-0849 jennifer.manns@baycare.org

Principal Investigator:

Don E. Eslin

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Site Public Contact

404-785-0232 Olivia.Floyd@choa.org

Principal Investigator:

Jason R. Fangusaro

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Wade T. Kyono

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774 eslinget@slhs.org

Principal Investigator:

Martha M. Pacheco

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Alicia Lenzen

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Dipti S. Dighe

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Site Public Contact

773-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Wendy S. Darlington

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Eugene Suh

OSF Children's Hospital of Illinois

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Site Public Contact

309-624-4945 ChildrensHospitalofIllinois@osfhealthcare.org

Principal Investigator:

Prerna Kumar

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Sandeep Batra

317-944-8784 batras@iu.edu

Principal Investigator:

Sandeep Batra

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-8912 samantha.mallory@unitypoint.org

Principal Investigator:

Samantha L. Mallory

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Andrew P. Groves

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

James T. Badgett

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-629-5500 CancerResource@nortonhealthcare.org

Principal Investigator:

Michael J. Ferguson

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Site Public Contact

504-842-8084 Elisemarie.curry@ochsner.org

Principal Investigator:

Craig Lotterman

Eastern Maine Medical Center

Recruiting

Bangor, Maine, United States, 04401

Contacts

Site Public Contact

207-973-4274

Principal Investigator:

Daniel L. Callaway

Maine Children's Cancer Program

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Site Public Contact

207-396-8670 clinicalresearch@mainehealth.org

Principal Investigator:

Stanley Chaleff

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-9083

Principal Investigator:

Jason M. Fixler

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804 jhcccro@jhmi.edu

Principal Investigator:

Kenneth J. Cohen

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Kee Kiat Yeo

C S Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Andrea T. Franson

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Stephanie A. Toll

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Children's

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Site Public Contact

248-551-7695

Principal Investigator:

Marie V. Nelson

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Site Public Contact

612-813-5913 pauline.mitby@childrensmn.org

Principal Investigator:

Michael K. Richards

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Joseph Z. Wilson

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Amanda Strobel

University of Missouri Children's Hospital

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Site Public Contact

573-882-1960 snwq62@health.missouri.edu

Principal Investigator:

Barbara A. Gruner

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-302-6808 COGResearchGroup@cmh.edu

Principal Investigator:

Keith J. August

Cardinal Glennon Children's Medical Center

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Site Public Contact

314-268-4000

Principal Investigator:

William S. Ferguson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Mohamed S. Abdelbaki

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Robin D. Hanson

Children's Hospital and Medical Center of Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-955-3949

Principal Investigator:

Jill C. Beck

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941 unmcrsa@unmc.edu

Principal Investigator:

Jill C. Beck

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Site Public Contact

775-982-5050 Renown-CRD@renown.org

Principal Investigator:

Alan K. Ikeda

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Site Public Contact

800-639-6918 cancer.research.nurse@dartmouth.edu

Principal Investigator:

Angela Ricci

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Derek R. Hanson

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Site Public Contact

973-971-5900

Principal Investigator:

Kathryn L. Laurie

Saint Peter's University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Site Public Contact

732-745-8600 kcovert@saintpetersuh.com

Principal Investigator:

Nibal A. Zaghloul

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

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-8675

Principal Investigator:

Nehal S. Parikh

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Site Public Contact

973-926-7230 Christine.Kosmides@rwjbh.org

Principal Investigator:

Nehal S. Parikh

Saint Joseph's Regional Medical Center

Recruiting

Paterson, New Jersey, United States, 07503

Contacts

Site Public Contact

973-754-2207 HallL@sjhmc.org

Principal Investigator:

Alissa Kahn

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Site Public Contact

518-262-5513

Principal Investigator:

Lauren R. Weintraub

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Site Public Contact

718-765-2500

Principal Investigator:

Mahmut Y. Celiker

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355 askroswell@roswellpark.org

Principal Investigator:

Clare J. Twist

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

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Site Public Contact

718-470-3460

Principal Investigator:

Mark P. Atlas

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Site Public Contact

CancerTrials@nyulangone.org

Principal Investigator:

Elizabeth A. Raetz

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Sameer Farouk Sait

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

David N. Korones

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Laura E. Hogan

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Melanie A. Comito

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Site Public Contact

718-379-6866 eskwak@montefiore.org

Principal Investigator:

Alice Lee

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866 eskwak@montefiore.org

Principal Investigator:

Alice Lee

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Site Public Contact

914-594-3794

Principal Investigator:

Andrew J. Bellantoni

Carolinas Medical Center/Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Joel A. Kaplan

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Jessica M. Sun

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Site Public Contact

252-744-1015 eubankss@ecu.edu

Principal Investigator:

Andrea R. Whitfield

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Sarah Supples

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-323-5760 OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Samuel J. Milanovich

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Site Public Contact

330-543-3193

Principal Investigator:

Erin Wright

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Site Public Contact

513-636-2799 cancer@cchmc.org

Principal Investigator:

Trent R. Hummel

Rainbow Babies and Childrens Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

216-844-5437

Principal Investigator:

Duncan S. Stearns

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Site Public Contact

614-722-6039 Melinda.Triplet@nationwidechildrens.org

Principal Investigator:

Mark A. Ranalli

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Site Public Contact

800-228-4055

Principal Investigator:

Jordan M. Wright

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Contacts

Site Public Contact

419-824-1842 PCIOncResearch@promedica.org

Principal Investigator:

Jamie L. Dargart

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Site Public Contact

419-824-1842 PCIOncResearch@promedica.org

Principal Investigator:

Jamie L. Dargart

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator:

Rene Y. McNall-Knapp

Legacy Emanuel Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Site Public Contact

503-413-2560

Principal Investigator:

Jason M. Glover

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080 trials@ohsu.edu

Principal Investigator:

Neha J. Patel

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Site Public Contact

610-402-9543 Morgan_M.Horton@lvhn.org

Principal Investigator:

Jacob A. Troutman

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251 cancerresearch@geisinger.edu

Principal Investigator:

Jagadeesh Ramdas

Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Site Public Contact

717-531-6012

Principal Investigator:

Lisa M. McGregor

Saint Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Site Public Contact

215-427-8991

Principal Investigator:

Gregory E. Halligan

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Site Public Contact

412-692-8570 jean.tersak@chp.edu

Principal Investigator:

James T. Felker

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Bradley DeNardo

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321 hcc-clinical-trials@musc.edu

Principal Investigator:

Jacqueline M. Kraveka

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Site Public Contact

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Stuart L. Cramer

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Aniket Saha

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317 Kim.Williams3@prismahealth.org

Principal Investigator:

Aniket Saha

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Site Public Contact

605-312-3320 OncologyClinicalTrialsSF@SanfordHealth.org

Principal Investigator:

Kayelyn J. Wagner

East Tennessee Childrens Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Site Public Contact

865-541-8266

Principal Investigator:

Susan E. Spiller

Saint Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Site Public Contact

888-226-4343 referralinfo@stjude.org

Principal Investigator:

Aditi Bagchi

The Children's Hospital at TriStar Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Site Public Contact

615-342-1919

Principal Investigator:

Clinton M. Carroll

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Adam J. Esbenshade

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Site Public Contact

512-628-1902 TXAUS-DL-SFCHemonc.research@ascension.org

Principal Investigator:

Shannon M. Cohn

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Site Public Contact

361-694-5311 Crystal.DeLosSantos@dchstx.org

Principal Investigator:

Nkechi I. Mba

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Daniel C. Bowers

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

Principal Investigator:

Daniel C. Bowers

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Site Public Contact

915-298-5444 ranjan.bista@ttuhsc.edu

Principal Investigator:

Benjamin Carcamo

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

682-885-2103 CookChildrensResearch@cookchildrens.org

Principal Investigator:

Sibo Zhao

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354 burton@bcm.edu

Principal Investigator:

Jack M. Su

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Najat C. Daw

713-792-6315 ndaw@mdanderson.org

Principal Investigator:

Najat C. Daw

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Site Public Contact

210-704-2894 bridget.medina@christushealth.org

Principal Investigator:

Julie Voeller

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-575-6240 Vinod.GidvaniDiaz@hcahealthcare.com

Principal Investigator:

Jose M. Esquilin

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-450-3800 phoresearchoffice@uthscsa.edu

Principal Investigator:

Shafqat Shah

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Site Public Contact

254-724-5407

Principal Investigator:

Nicholas W. McGregor

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Site Public Contact

801-585-5270

Principal Investigator:

Priya Chan

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990 rpo@uvm.edu

Principal Investigator:

Jessica L. Heath

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303 uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Brian C. Belyea

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Site Public Contact

757-668-7243 CCBDCresearch@chkd.org

Principal Investigator:

Melissa S. Mark

Carilion Children's

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Site Public Contact

540-266-6238 wpmccarty@carilionclinic.org

Principal Investigator:

Erwood G. Edwards

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Site Public Contact

866-987-2000

Principal Investigator:

Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Site Public Contact

800-228-6618 HopeBeginsHere@providence.org

Principal Investigator:

Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Site Public Contact

253-403-1461 research@multicare.org

Principal Investigator:

Robert G. Irwin

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Site Public Contact

253-968-6144 melissa.a.forouhar.mil@health.mil

Principal Investigator:

Melissa A. Forouhar

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Site Public Contact

304-293-7374 cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Ashley E. Meyer

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Site Public Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Principal Investigator:

Nicholas J. Pytel

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Principal Investigator:

Nicholas J. Pytel

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Site Public Contact

403-220-6898 research4kids@ucalgary.ca

Principal Investigator:

Victor A. Lewis

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Site Public Contact

780-407-8798 pedsoncologyresearch@ahs.ca

Principal Investigator:

Sarah J. McKillop

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Site Public Contact

604-875-2345

Principal Investigator:

Rebecca J. Deyell

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Site Public Contact

866-561-1026 ctu_web@cancercare.mb.ca

Principal Investigator:

Stephanie M. Villeneuve

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Site Public Contact

902-470-8520 Research@iwk.nshealth.ca

Principal Investigator:

Chelsea Ash

McMaster Children's Hospital at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Site Public Contact

905-521-2100

Principal Investigator:

Uma H. Athale

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Site Public Contact

416-813-7654 ask.CRS@sickkids.ca

Principal Investigator:

Pak Yin Anthony Liu

The Montreal Children's Hospital of the MUHC

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Contacts

Site Public Contact

514-412-4445 info@thechildren.com

Principal Investigator:

Stephanie Mourad

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Site Public Contact

514-345-4931 yvan.samson@umontreal.ca

Principal Investigator:

Monia Marzouki

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Site Public Contact

819-820-6480 crcinformation.chus@ssss.gouv.qc.ca

Principal Investigator:

Josee Brossard

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

Recruiting

Québec, Canada, G1V 4G2

Contacts

Site Public Contact

418-525-4444 rechclinique@crchudequebec.ulaval.ca

Principal Investigator:

Bruno Michon

More Information

Sponsor

Children's Oncology Group

Last update posted

Aug 25, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-08-25.