A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

NCT ID: NCT05382338

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2027-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of sodium thiosulfate (STS) infusion administered during cisplatin-containing chemotherapy cycles (compared to a historical cohort selected from ACNS0331 which received chemotherapy without STS) in reducing hearing loss in children with newly-diagnosed average-risk medulloblastoma.

II. To estimate and monitor event-free survival (EFS) in this study against a carefully selected cohort from ACNS0331 to guard against loss of efficacy due to STS.

SECONDARY OBJECTIVES:

I. To estimate and monitor overall survival (OS) in this study against a carefully selected control cohort from ACNS0331.

II. To estimate the incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort.

III. To estimate the incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts.

IV. To evaluate full scale intelligence neurocognitive outcomes and trajectories of patients with average-risk medulloblastoma treated with STS compared to the control cohort from ACNS0331.

V. To evaluate quality of life and psychosocial outcomes and trajectories of patients with average-risk medulloblastoma treated with STS compared to published norms.

VI. To estimate and monitor EFS, OS, and patterns of recurrence in patients with low-risk features treated using a reduced craniospinal radiation approach.

VII. To evaluate the trajectory of hearing loss in medulloblastoma patients treated with STS.

VIII. To evaluate household material hardship as a social determinant of neurocognitive, quality of life, and psychosocial outcomes in patients with average-risk and low risk medulloblastoma.

EXPLORATORY OBJECTIVES:

I. To obtain paired blood and tumor tissue to be banked for future biology studies involving comprehensive molecular analysis, including but not limited to whole exome sequencing, ribonucleic acid (RNA) sequencing, and methylation.

II. To bank blood and cerebrospinal fluid for future studies. III. To evaluate attention, processing speed, memory, and executive function neurocognitive outcomes and trajectories, as well as hearing-related quality of life outcomes and trajectories, of patients with average-risk medulloblastoma treated with STS.

IV. To evaluate neurocognitive, quality of life, and psychosocial outcomes of patients with low-risk features treated using a reduced craniospinal radiation approach.

OUTLINE:

CHEMORADIOTHERAPY: Patients undergo radiation therapy 5 days per week for 6 weeks (weeks 1-6) and receive vincristine intravenously (IV) once weekly on weeks 2-7 in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Beginning 4 weeks after chemoradiotherapy, patients receive lomustine orally (PO) on day 1 of cycles 1, 2, 4, 5, 7, and 8, cisplatin IV over 6 hours on day 1 of cycles 1, 2, 4, 5, 7, and 8, sodium thiosulfate IV over 15 minutes on day 1 of cycles 1, 2, 4, 5, 7, and 8, and cyclophosphamide IV over 30-60 minutes on days 1 and 2 of cycles 3, 6, and 9. Patients also receive vincristine IV on days 1, 8, and 15 of cycles 1, 2, 4, 5, 7, and 8, and on days 1 and 8 of cycles 3, 6, and 9. Treatment repeats every 6 weeks (cycles 1, 2, 4, 5, 7 and 8) or every 4 weeks (cycles 3, 6, and 9) for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo magnetic resonance imaging (MRI) and collection of cerebrospinal fluid (CSF) throughout the study. Patients may also optionally undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for years 1-2, every 6 months for years 3-4, and then annually for years 5-10.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Medulloblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (chemoradiotherapy, maintenance)

See Detailed Description.

Group Type EXPERIMENTAL

Audiometric Test

Intervention Type PROCEDURE

Ancillary studies

Auditory Brainstem Response

Intervention Type PROCEDURE

Ancillary studies

Biospecimen Collection

Intervention Type PROCEDURE

Undergo CSF and blood sample collection

Cisplatin

Intervention Type DRUG

Given IV

Cyclophosphamide

Intervention Type DRUG

Given IV

Lomustine

Intervention Type DRUG

Given PO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo radiation therapy

Sodium Thiosulfate

Intervention Type DRUG

Given IV

Survey Administration

Intervention Type OTHER

Ancillary studies

Vincristine

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Audiometric Test

Ancillary studies

Intervention Type PROCEDURE

Auditory Brainstem Response

Ancillary studies

Intervention Type PROCEDURE

Biospecimen Collection

Undergo CSF and blood sample collection

Intervention Type PROCEDURE

Cisplatin

Given IV

Intervention Type DRUG

Cyclophosphamide

Given IV

Intervention Type DRUG

Lomustine

Given PO

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Radiation Therapy

Undergo radiation therapy

Intervention Type RADIATION

Sodium Thiosulfate

Given IV

Intervention Type DRUG

Survey Administration

Ancillary studies

Intervention Type OTHER

Vincristine

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Audiometric Testing Audiometry Hearing Test ABR BAEP BAER Brainstem Auditory Evoked Potentials Brainstem Auditory Evoked Response Biological Sample Collection Biospecimen Collected Specimen Collection Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Asta B 518 B 518 B-518 B518 Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamide Monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR 138719 WR- 138719 WR-138719 WR138719 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl- Belustin Belustine CCNU Cecenu CeeNU Chloroethylcyclohexylnitrosourea Citostal Gleostine Lomeblastin Lomustinum Lucostin Lucostine N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea Prava RB-1509 WR-139017 Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Quality of Life Assessment Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Cyanide Antidote Package Disodium Thiosulfate S-Hydril Sodium Hyposulfate Sodium Thiosulfate Pentahydrate Sodium Thiosulphate Sodothiol Thiosulfate, Sodium, Pentahydrate Thiosulfuric Acid Disodium Salt LCR Leurocristine VCR Vincrystine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment
* PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis

* Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening
* PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)
* PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery
* PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031.

* Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol
* PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1

* Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection
* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1
* Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment
* Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative
* Average-risk cohort

* Clinico-pathologic criteria:

* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:

* SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss
* Group 3, MYC normal, no isochromosome 17q
* Group 4, no chromosome 11 loss
* Low-risk features cohort

* Clinico-pathologic criteria:

* M0 disease
* No diffuse anaplastic histology AND
* Molecular criteria:

* Group 4, chromosome 11 loss
* Patients must have negative lumbar CSF cytology

* Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively
* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed
* Patients must weigh \> 10 kg
* Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)
* 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 count \[RBC\] transfusions) (within 7 days prior to enrollment)
* A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows:

* 4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female)
* 6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female)
* 10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female)
* 13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female)
* \>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). 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 (within 7 days prior to enrollment)
* Serum glutamic pyruvic 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, a coma or assisted ventilation at the time of study enrollment
* Auditory function defined as:

* Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment
* 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

Exclusion Criteria

* Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
* Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
* Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)
* Pregnancy and Breastfeeding:

* 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
* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ralph Salloum

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status SUSPENDED

USA Health Strada Patient Care Center

Mobile, Alabama, United States

Site Status RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Valley Children's Hospital

Madera, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

Children's Hospital of Orange County

Orange, California, United States

Site Status RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

Children's National Medical Center

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

Site Status RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status RECRUITING

Corewell Health Children's

Royal Oak, Michigan, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status RECRUITING

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status RECRUITING

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Site Status RECRUITING

Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

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

New Hyde Park, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

New York Medical College

Valhalla, New York, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Dayton Children's Hospital

Dayton, Ohio, United States

Site Status RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Site Status RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Site Status RECRUITING

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

El Paso Children's Hospital

El Paso, Texas, United States

Site Status RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Site Status RECRUITING

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

Site Status RECRUITING

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

Québec, , Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Site Public Contact

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACNS2031

Identifier Type: -

Identifier Source: org_study_id

NCI-2022-04866

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACNS2031

Identifier Type: OTHER

Identifier Source: secondary_id

ACNS2031

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180886

Identifier Type: NIH

Identifier Source: secondary_id

View Link