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NCT05382338RecruitingPhase 3

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

A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
225 (estimated)
First submitted
15 Apr 2022
Start date
20 Feb 2023
Primary completion date
31 Dec 2029
Lead sponsor
Children's Oncology Group
NCT number
NCT05382338

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 225
  • From 20 Feb 2023 to the primary completion date, 31 Dec 2029
  • 111 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids
  • 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

Other illness

  • 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 any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)

Who the study is looking for

  • 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

Age in the registry: 4 years to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (111)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IWK Health Centre
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HalifaxCanadaRecruiting
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaRecruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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QuébecCanadaRecruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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SherbrookeCanadaRecruiting
CancerCare Manitoba
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WinnipegCanadaRecruiting
Children's Hospital Medical Center of Akron
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AkronUnited StatesRecruiting
Albany Medical Center
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AlbanyUnited StatesRecruiting
C S Mott Children's Hospital
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Ann ArborUnited StatesRecruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesRecruiting
Children's Hospital Colorado
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AuroraUnited StatesRecruiting
Dell Children's Medical Center of Central Texas
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AustinUnited StatesRecruiting
Sinai Hospital of Baltimore
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BaltimoreUnited StatesRecruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesRecruiting
Children's Hospital of Alabama
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BirminghamUnited StatesActive, not recruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Massachusetts General Hospital Cancer Center
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BostonUnited StatesSuspended
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
University of Illinois
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ChicagoUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesRecruiting
Prisma Health Richland Hospital
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ColumbiaUnited StatesRecruiting
Nationwide Children's Hospital
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ColumbusUnited StatesRecruiting
Driscoll Children's Hospital
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Corpus ChristiUnited StatesRecruiting
Medical City Dallas Hospital
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DallasUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Dayton Children's Hospital
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DaytonUnited StatesRecruiting
Blank Children's Hospital
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Des MoinesUnited StatesRecruiting
Children's Hospital of Michigan
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DetroitUnited StatesRecruiting
El Paso Children's Hospital
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El PasoUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesRecruiting
BI-LO Charities Children's Cancer Center
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GreenvilleUnited StatesRecruiting
East Carolina University
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GreenvilleUnited StatesRecruiting
Connecticut Children's Medical Center
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HartfordUnited StatesRecruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesRecruiting
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
University of Mississippi Medical Center
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JacksonUnited StatesRecruiting
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesRecruiting
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesRecruiting
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesRecruiting
Arkansas Children's Hospital
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Little RockUnited StatesRecruiting
Loma Linda University Medical Center
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Loma LindaUnited StatesRecruiting
Miller Children's and Women's Hospital Long Beach
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Long BeachUnited StatesRecruiting
Children's Hospital Los Angeles
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Los AngelesUnited StatesRecruiting
Norton Children's Hospital
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LouisvilleUnited StatesRecruiting
Valley Children's Hospital
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MaderaUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Nicklaus Children's Hospital
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MiamiUnited StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesRecruiting
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesRecruiting
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesRecruiting
USA Health Strada Patient Care Center
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MobileUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesSuspended
Newark Beth Israel Medical Center
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NewarkUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New BrunswickUnited StatesRecruiting
Saint Peter's University Hospital
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New BrunswickUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
The Steven and Alexandra Cohen Children's Medical Center of New York
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New Hyde ParkUnited StatesSuspended
Children's Hospital New Orleans
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New OrleansUnited StatesRecruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesRecruiting
Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Children's Hospital of The King's Daughters
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NorfolkUnited StatesRecruiting
Kaiser Permanente-Oakland
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OaklandUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesRecruiting
Children's Hospital of Orange County
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OrangeUnited StatesRecruiting
Arnold Palmer Hospital for Children
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OrlandoUnited StatesRecruiting
Nemours Children's Hospital
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OrlandoUnited StatesRecruiting
Saint Joseph's Regional Medical Center
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PatersonUnited StatesRecruiting
Nemours Children's Clinic - Pensacola
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PensacolaUnited StatesRecruiting
OSF Children's Hospital of Illinois
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PeoriaUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Phoenix Childrens Hospital
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PhoenixUnited StatesRecruiting
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesRecruiting
Legacy Emanuel Children's Hospital
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PortlandUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Rhode Island Hospital
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ProvidenceUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Mayo Clinic in Rochester
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RochesterUnited StatesRecruiting
Corewell Health Children's
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Royal OakUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Children's Hospital of San Antonio
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San AntonioUnited StatesRecruiting
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesRecruiting
Rady Children's Hospital - San Diego
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San DiegoUnited StatesRecruiting
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesRecruiting
Seattle Children's Hospital
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SeattleUnited StatesRecruiting
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesRecruiting
Providence Sacred Heart Medical Center and Children's Hospital
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SpokaneUnited StatesRecruiting
Southern Illinois University School of Medicine
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SpringfieldUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Cardinal Glennon Children's Medical Center
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St LouisUnited StatesRecruiting
Stony Brook University Medical Center
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Stony BrookUnited StatesRecruiting
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesRecruiting
State University of New York Upstate Medical University
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SyracuseUnited StatesRecruiting
Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesRecruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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ToledoUnited StatesRecruiting
New York Medical College
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ValhallaUnited StatesRecruiting
Children's National Medical Center
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Washington D.C.United StatesRecruiting
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.