Recruiting
Phase 3

Iobenguane I-131 & Lorlatinib

Sponsor:

Children's Oncology Group

Code:

NCT03126916

Conditions

Ganglioneuroblastoma

Ganglioneuroblastoma, Nodular

Neuroblastoma

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Interventions

Autologous Hematopoietic Stem Cell Transplantation

Biospecimen Collection

Bone Marrow Aspiration and Biopsy

Busulfan

Carboplatin

Study Details

Brief summary:

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Conditions

Ganglioneuroblastoma

Ganglioneuroblastoma, Nodular

Neuroblastoma

Study ID

NCT03126916

Start date

May 14, 2018

Status verified date

Feb, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be >= 365 days and =< 30 years of age at diagnosis
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:

  • Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:

  • MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
  • Age > 547 days regardless of biologic features
  • Patients with INRG stage MS disease with MYCN amplification
  • Patients with INRG stage L2 disease with MYCN amplification
  • Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M
  • Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); 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 will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) 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:

  • 1 to < 2 years: male = 0.6; female = 0.6
  • 2 to < 6 years: male = 0.8; female = 0.8
  • 6 to < 10 years: male = 1; female = 1
  • 10 to < 13 years: male = 1.2; female = 1.2
  • 13 to < 16 years: male = 1.5; female = 1.4
  • >= 16 years: male = 1.7; female = 1.4
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) < 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (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
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be > 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients < 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan/cyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems 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:

  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: 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 for female patients of childbearing potential
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants
  • FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): 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 for female patients of childbearing potential
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants
  • PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): 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

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (chemotherapy, HSCT, EBRT)

See Arm A in detailed description.

experimental: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)

See Arm B in detailed description.

experimental: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)

See Arm C in detailed description. Closed to accrual as of 12/17/20.

experimental: Arm D (chemotherapy, HSCT, EBRT)

See Arm D in detailed description.

experimental: Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

See Arm E in detailed description.

Interventions

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous HSCT

Biospecimen Collection

Undergo blood sample collection

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Busulfan

Given IV

Carboplatin

Given IV

Cisplatin

Given IV

Computed Tomography

Undergo CT scan

Cyclophosphamide

Given IV

Dexrazoxane Hydrochloride

Given IV

Dinutuximab

Given IV

Doxorubicin Hydrochloride

Given IV

Echocardiography Test

Undergo echocardiography

Etoposide Phosphate

Given IV

External Beam Radiation Therapy

Undergo EBRT

Iobenguane I-123

Given 123 I-MIBG

Iobenguane I-131

Given IV

Isotretinoin

Given PO

Lorlatinib

Given PO

Magnetic Resonance Imaging

Undergo MRI

Melphalan Hydrochloride

Given IV

Multigated Acquisition Scan

Undergo MUGA scan

Positron Emission Tomography

Undergo PET scan

Sargramostim

Given SC

Therapeutic Conventional Surgery

Undergo standard of care surgery

Thiotepa

Given IV

Topotecan Hydrochloride

Given IV

Vincristine Sulfate

Given IV

Primary outcome measure

  • Event free survival (EFS) (Arm A, B, D, and E) [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Elizabeth D. Alva

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Francis K. Eshun

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

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Albert Kheradpour

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

323-361-4110

Principal Investigator:

Araz Marachelian

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

Principal Investigator:

Ruetima Titapiwatanakun

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Elyssa M. Rubin

Lucile Packard Children's Hospital Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Jay Michael S. Balagtas

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

Naval Medical Center -San Diego

Recruiting

San Diego, California, United States, 92134

Contacts

Site Public Contact

619-532-8712

Principal Investigator:

Yoko T. Udaka

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Kieuhoa T. Vo

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Margaret E. Macy

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Contacts

Principal Investigator:

Florence Choo

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

Principal Investigator:

Farzana Pashankar

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Vibhuti Agarwal

Children's National Medical Center

Recruiting

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

Contacts

Principal Investigator:

Jeffrey S. Dome

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Principal Investigator:

Emad K. Salman

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Brian Stover

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847OHR@mhs.net

Principal Investigator:

Iftikhar Hanif

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Vibhuti Agarwal

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

Principal Investigator:

Fouad M. Hajjar

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Principal Investigator:

Vibhuti Agarwal

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

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

Principal Investigator:

William T. Cash

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Principal Investigator:

Andrew L. Pendleton

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

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:

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

Principal Investigator:

Susan L. Cohn

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

Principal Investigator:

Rebecca E. McFall

OSF Children's Hospital of Illinois

Recruiting

Peoria, Illinois, United States, 61637

Contacts

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:

Sandeep Batra

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

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

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

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

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

Principal Investigator:

Eric C. Larsen

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

Principal Investigator:

Allen R. Chen

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Suzanne Shusterman

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

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Roland L. Chu

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

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

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:

Wendy Allen-Rhoades

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

Principal Investigator:

Barbara A. Gruner

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Keith J. August

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

Principal Investigator:

Jill C. Beck

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Principal Investigator:

Alan K. Ikeda

Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Principal Investigator:

Alan K. Ikeda

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Principal Investigator:

Alan K. Ikeda

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Principal Investigator:

Alan K. Ikeda

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

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

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

Principal Investigator:

Teena Bhatla

Saint Joseph's Regional Medical Center

Recruiting

Paterson, New Jersey, United States, 07503

Contacts

Site Public Contact

973-754-2207HallL@sjhmc.org

Principal Investigator:

Alissa Kahn

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Jessica M. Valdez

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

Principal Investigator:

Clare J. Twist

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

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

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

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Nobuko Hijiya

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Jeffrey R. Andolina

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 - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

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

Principal Investigator:

Douglas J. Scothorn

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

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

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

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

Principal Investigator:

Samuel J. Milanovich

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Robin E. Norris

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

Principal Investigator:

Matteo M. Trucco

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

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

Principal Investigator:

Jamie L. Dargart

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

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

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Jacob A. Troutman

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

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

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Rochelle Bagatell

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

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

Principal Investigator:

Jacqueline M. Kraveka

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Stuart L. Cramer

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Aniket Saha

Sanford USD Medical Center - Sioux Falls

Recruiting

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

Contacts

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

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

Principal Investigator:

Shannon M. Cohn

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Principal Investigator:

Nkechi I. Mba

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Tanya C. Watt

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Principal Investigator:

Benjamin Carcamo

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Chelsee Greer

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Jennifer H. Foster

Covenant Children's Hospital

Recruiting

Lubbock, Texas, United States, 79410

Contacts

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

Principal Investigator:

Julie Voeller

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Jose M. Esquilin

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Anne-Marie R. Langevin

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

802-656-8990rpo@uvm.edu

Principal Investigator:

Jessica L. Heath

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

Principal Investigator:

Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

Robert G. Irwin

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Principal Investigator:

Melissa A. Forouhar

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Ashley E. Meyer

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Catherine A. Long

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Margo L. Hoover-Regan

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Michelle A. Manalang

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727MACCCTO@mcw.edu

Principal Investigator:

Angela Steineck

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Stephanie M. Villeneuve

Janeway Child Health Centre

Recruiting

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

Contacts

Principal Investigator:

Lisa A. Goodyear

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

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

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Principal Investigator:

Laura Wheaton

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

Principal Investigator:

Daniel A. Morgenstern

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Monia Marzouki

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

Recruiting

Québec, Canada, G1V 4G2

Contacts

Principal Investigator:

Bruno Michon

More Information

Sponsor

Children's Oncology Group

Last update posted

Aug 25, 2026

Last verified

Feb, 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.