Recruiting

Phase 3

Dinutuximab with ChemotherapyDinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06172296

Conditions

Ganglioneuroblastoma, Nodular

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Carboplatin

Cisplatin

Study Details

Brief summary:

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

Conditions

Ganglioneuroblastoma, Nodular

Neuroblastoma

Study ID

NCT06172296

Start date

Apr 19, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative (MCI), prior to enrollment on ANBL2131
≤ 30 years at the time of initial diagnosis with high-risk disease
\* Must have a diagnosis of neuroblastoma (NBL) or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines

Newly diagnosed, high risk neuroblastoma (HRNBL) defined as one of the following:

Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M and MYCN amplification
Age ≥ 547 days and INRG stage M regardless of biologic features (clinical MYCN testing not required prior to enrollment)
Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to stage M without systemic chemotherapy
Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to stage M without systemic chemotherapy (clinical MYCN testing not required prior to enrollment)
Patients must have a body surface area (BSA) ≥ 0.25 m\^2
No prior anti-cancer therapy except as outlined below:

Patients initially recognized to have high-risk disease treated with topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing, and with consent
Patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease but subsequently found to meet the criteria
Patients who received localized emergency radiation to sites of life threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
Human immunodeficiency virus (HIV) -infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
A serum creatinine based on age/sex as follows:

1 month to < 6 months: Male 0.4 mg/dL and female 0.4mg/dL
6 months to < 1 year: Male 0.5 mg/dL and female 0.5 mg/dL
1 to < 2 years: Male 0.6 mg/dL and female 0.6 mg/dL
2 to < 6 years: Male 0.8 mg/dL and female 0.8 mg/dL
6 to < 10 years: Male 1 mg/dL and female 1 mg/dL
10 to < 13 years: Male 1.2 mg/dL and female 1.2 mg/dL
13 to < 16 years: Male 1.5 mg/dL and female 1.4 mg/dL
≥ 16 years: Male 1.7 mg/dL and female 1.4 mg/dL

The threshold creatinine values were derived from the Schwartz formula for estimating glomerular filtration rate (GFR) utilizing child length and stature data published by the Centers for Disease Control (CDC)
or a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 or
or a GFR ≥ 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method or direct small molecule clearance method (iothalamate or other molecule per institutional standard)

Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
Serum glutamic pyruvic transaminase (SGPT) (Alanine aminotransferase \[ALT\]) ≤ 10 x ULN\*

Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
\* Shortening fraction of ≥ 27% by echocardiogram, or

Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram
Ability to tolerate Peripheral Blood Stem Cell (PBSC) collection:

No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure

Exclusion Criteria:

Patients who are 365-546 days of age with INRG Stage M and MYCN non-amplified NBL, irrespective of additional biologic features
Patients ≥ 547 days of age with INRG Stage L2, MYCN non-amplified NBL, regardless of additional biologic features
Patients with known bone marrow failure syndromes
Patients on chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine, corticosteroids) for reasons other than prevention/treatment of allergic reactions and adrenal replacement therapy are not eligible. Topical and inhaled corticosteroids are acceptable
Patients with a primary immunodeficiency syndrome who require ongoing immune globulin replacement therapy
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required prior to enrollment for female patients of childbearing potential
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
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

Study Design

Enrollment

478 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (SOC treatment)

See detailed description

experimental: Arm B (Dinutuximab in induction)

See detailed description

Interventions

Biospecimen Collection

Undergo blood and urine sample collection

Bone Marrow Aspiration

Undergo bone marrow aspiration

Bone Marrow Biopsy

Undergo bone marrow biopsy

Carboplatin

Given IV

Cisplatin

Given IV

Computed Tomography

Undergo CT scan

Cyclophosphamide

Given IV

Dinutuximab

Given IV

Doxorubicin

Given IV

Echocardiography Test

Undergo ECHO

Etoposide

Given IV

FDG-Positron Emission Tomography and Computed Tomography Scan

Undergo FDG PET

Hematopoietic Cell Transplantation

Undergo stem cell infusion

Irinotecan

Given IV

Isotretinoin

Given PO

Leukapheresis

Undergo apheresis

Magnetic Resonance Imaging

Undergo MRI

Melphalan

Given IV

Multigated Acquisition Scan

Undergo MUGA

Radiation Therapy

Undergo radiation therapy

Radionuclide Imaging

Undergo I-MIBG scan

Survey Administration

Ancillary studies

Temozolomide

Given PO or via NG or G tube

Thiotepa

Given IV

Topotecan

Given IV

Tumor Resection

Undergo tumor resection surgery

Vincristine

Given IV

Primary outcome measure

Event free survival (EFS) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

205-638-9285 oncologyresearch@peds.uab.edu

Principal Investigator:

Elizabeth D. Alva

USA Health Strada Patient Care Center

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Site Public Contact

800-388-8721

Principal Investigator:

Hamayun Imran

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:

Alok K. Kothari

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:

Robert M. Cooper

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673 becomingapatient@coh.org

Principal Investigator:

Hung C. 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:

Araz Marachelian

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

Mattel Children's Hospital UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Site Public Contact

310-825-6708

Principal Investigator:

Satiro N. De Oliveira

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Site Public Contact

559-353-3000 Research@valleychildrens.org

Principal Investigator:

Ruetima Titapiwatanakun

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Site Public Contact

510-428-3264 PedOncRschOAK@ucsf.edu

Principal Investigator:

Jennifer G. Michlitsch

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

Sutter Medical Center Sacramento

Recruiting

Sacramento, California, United States, 95816

Contacts

Site Public Contact

clinicalresearch@sutterhealth.org

Principal Investigator:

Sandra Baril

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Marcio H. Malogolowkin

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:

Arun A. Rangaswami

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:

Navin R. Pinto

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Site Public Contact

860-545-9981

Principal Investigator:

Michael S. Isakoff

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Farzana Pashankar

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

Broward Health Medical Center

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Site Public Contact

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

Principal Investigator:

Hector M. Rodriguez-Cortes

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

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847 OHR@mhs.net

Principal Investigator:

Iftikhar Hanif

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:

Meghan McCormick

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Public Contact

888-624-2778

Principal Investigator:

Maggie E. Fader

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Site Public Contact

407-303-2090 FH.Cancer.Research@flhosp.org

Principal Investigator:

Fouad M. Hajjar

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

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:

Jennifer B. Dean

Saint Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Site Public Contact

561-822-4745

Principal Investigator:

Matthew D. Ramirez

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:

William T. Cash

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Site Public Contact

912-350-7887 Lorraine.OHara@hcahealthcare.com

Principal Investigator:

Andrew L. Pendleton

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

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Elizabeth A. Sokol

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:

Ami V. Desai

Advocate Children's Hospital-Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Site Public Contact

847-723-7570

Principal Investigator:

Rebecca E. McFall

Advocate Children's Hospital-Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Rebecca E. McFall

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

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Gregory P. Brandt

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

Marissa Just

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

Wesley Medical Center

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Site Public Contact

316-962-7802 WesleyResearch@wesleymc.com

Principal Investigator:

Nathan S. Hall

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

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Site Public Contact

504-894-5377

Principal Investigator:

Maria C. Velez-Yanguas

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:

Sei-Gyung K. Sze

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Teresa A. York

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:

Allen R. Chen

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Kip R. Hartman

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Lauren H. Boal

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Suzanne Shusterman

C S Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Rajen Mody

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

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

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

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Site Public Contact

612-624-2620

Principal Investigator:

Robin L. Williams

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Peter Schoettler

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

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:

Frederick S. Huang

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

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Site Public Contact

702-384-0013 research@sncrf.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:

Katharine Offer

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:

Teena Bhatla

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

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

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Site Public Contact

212-263-4432 cancertrials@nyulangone.org

Principal Investigator:

Chana L. Glasser

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:

Julie I. Krystal

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

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Site Public Contact

212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Nobuko Hijiya

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Rafi R. Kazi

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 - 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

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Site Public Contact

828-213-7055 NCDV.ResearchRegulatory@HCAHealthcare.com

Principal Investigator:

Douglas J. Scothorn

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683 cancerclinicaltrials@med.unc.edu

Principal Investigator:

Thomas B. Alexander

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

Novant Health Presbyterian Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Site Public Contact

980-201-6360 kashah@novanthealth.org

Principal Investigator:

Holly Edington

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

Rainbow Babies and Childrens Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

216-844-5437

Principal Investigator:

Duncan S. Stearns

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100 TaussigResearch@ccf.org

Principal Investigator:

Matteo M. Trucco

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 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

Saint Francis Children's Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Site Public Contact

918-502-6720

Principal Investigator:

Jill A. Salo

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:

Susan J. Lindemulder

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

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

267-425-5544 CancerTrials@email.chop.edu

Principal Investigator:

Rochelle Bagatell

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:

Jean M. Tersak

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

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:

Jordan Fritch-Hanson

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:

Sara M. Federico

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:

Daniel J. Benedetti

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

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Tanya C. Watt

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:

Chelsee Greer

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:

Jennifer H. Foster

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

866-632-6789 askmdanderson@mdanderson.org

Principal Investigator:

Najat C. Daw

Covenant Children's Hospital

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Site Public Contact

806-725-8657 mbisbee@providence.org

Principal Investigator:

Kishor M. Bhende

UMC Cancer Center / UMC Health System

Recruiting

Lubbock, Texas, United States, 79415

Contacts

Site Public Contact

806-775-8590

Principal Investigator:

Erin K. Barr

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:

Aaron J. Sugalski

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Site Public Contact

801-585-5270

Principal Investigator:

Leonora R. Slatnick

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

Naval Medical Center - Portsmouth

Recruiting

Portsmouth, Virginia, United States, 23708-2197

Contacts

Site Public Contact

757-953-5939

Principal Investigator:

Karin Brockman

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

Edwards Comprehensive Cancer Center

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Site Public Contact

304-399-6566 Christina.Cole@chhi.org

Principal Investigator:

Mark A. Ranalli

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 - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

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

Principal Investigator:

Margo L. Hoover-Regan

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581 oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Michelle A. Manalang

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727 MACCCTO@mcw.edu

Principal Investigator:

Angela Steineck

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

Janeway Child Health Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Site Public Contact

709-777-8727 beverlyj.mitchell@easternhealth.ca

Principal Investigator:

Lisa A. Goodyear

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

Children's Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Site Public Contact

519-685-8306

Principal Investigator:

Shayna M. Zelcer

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Site Public Contact

613-737-7600

Principal Investigator:

Donna L. Johnston

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Site Public Contact

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

Principal Investigator:

Daniel A. Morgenstern

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

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

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.