A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Study Purpose

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink tumors in this patient population. Glioma is a type of cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when it is growing and spreading quickly. The term, risk, refers to the chance of the cancer coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the brainstem that controls functions like breathing, swallowing, speaking, and eye movements). This trial has two parts. The only difference in treatment between the two parts is that some subjects treated in Part 1 may receive a different dose of selinexor than the subjects treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to determine the dose of selinexor that can be given without causing side effects that are too severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from growing and may kill them. It is a type of small molecule inhibitor called selective inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells and shrink tumors. The combination of selinexor and radiation therapy may be effective in treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Months - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- PRE ENROLLMENT: Patients must be =< 25 years of age at the time of enrollment on APEC14B1 part A cnetral nervous system (CNS)/high grade glioma (HGG) pre-enrollment eligibility screening.

- Please note: - This required age range applies to pre-enrollment eligibility for all HGG patients.

Individual treatment protocols may have different age criteria.

- Non-DIPG patients with tumors that do not harbor an H3K27M-mutation and are >= 18 years of age will not be eligible to enroll on ACNS1821 (Step 1).

- PRE ENROLLMENT: Patient is suspected of having localized, newly diagnosed HGG, excluding metastatic disease, OR patient has an institutional diagnosis of DIPG.

- Please note: there are specific radiographic criteria for DIPG patient enrollment on ACNS1821 (Step 1) - PRE ENROLLMENT: - For patients with non-pontine tumors: Patients and/or their parents or legal guardians must have signed informed consent for eligibility screening on APEC14B1 Part A.

- For patients with DIPG: Patients and/or their parents or legal guardians must have signed informed consent for ACNS1821.

- PRE ENROLLMENT: - For patients with non-pontine tumors only, the specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 ASAP, preferably within 5 calendar days of definitive surgery.

- STEP 1: Patients must be >= 12 months and =< 21 years of age at the time of enrollment.

- STEP 1: Patients must have newly-diagnosed DIPG or HGG (including DMG).

- STEP 1: Stratum DIPG.

- Patients with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons on at least 1 axial T2 weighted image, are eligible.

No histologic confirmation is required.

- Patients with pontine tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2/3 of the pontine cross-sectional area with or without extrapontine extension) are eligible if the tumors are biopsied and proven to be high-grade gliomas (such as anaplastic astrocytoma, glioblastoma, high-grade glioma not otherwise specified [NOS], and/or H3 K27M-mutant) by institutional diagnosis.

- STEP 1: Stratum DMG (with H3 K27M mutation) - Patients must have newly-diagnosed non-pontine H3 K27M-mutant HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1.

- Note: Patients need not have either measurable or evaluable disease, i.e., DMG patients may have complete resection of their tumor prior to enrollment.

Primary spinal tumors are eligible for enrollment. For rare H3 K27M-mutant HGG in non-midline structures (e.g., cerebral hemispheres), these patients will be considered part of Stratum DMG.

- STEP 1: Stratum HGG (without H3 K27M mutation) - Patients must have newly-diagnosed non-pontine H3 K27M-wild type HGG without BRAF V600 or IDH1 mutations as confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1.

- Please note: - Patients who fall in this category and who are >= 18 years of age are not eligible due to another standard-of-care regimen (radiation/temozolomide) that is available.

- Patients need not have either measurable or evaluable disease, i.e., HGG patients may have complete resection of their tumor prior to enrollment.

Primary spinal tumors are eligible for enrollment.

- STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2.

Use Karnofsky for patients > 16 years of age and Lansky for patients =<16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

- STEP 1: Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to step 1 enrollment) - STEP 1: Platelet count >= 100,000/uL (transfusion independent) (within 7 days prior to step 1 enrollment) - STEP 1: Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (within 7 days prior to step 1 enrollment) - STEP 1: Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to step 1 enrollment) or.

A serum creatinine based on age/gender as follows (within 7 days prior to step 1 enrollment):

- Age / Maximum Serum Creatinine (mg/dL) - 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.

- STEP 1: Total bilirubin =< 1.5 x upper limit of normal (ULN) for age.

- STEP 1: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L.

For the purpose of this study, the ULN for SGPT is 45 U/L.

- STEP 1: Serum amylase =< 1.5 x ULN.

- STEP 1: Serum lipase =< 1.5 x ULN.

- STEP 1: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination.

- STEP 1: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.

- STEP 1: Patients must be enrolled and protocol therapy must begin no later than 31 days after the date of radiographic diagnosis (in the case of non-biopsied DIPG patients only) or definitive surgery, whichever is the later date (Day 0).

For patients who have a biopsy followed by resection, the date of resection will be considered the date of definitive diagnostic surgery. If a biopsy only was performed, the biopsy date will be considered the date of definitive diagnostic surgery.

Exclusion Criteria:

- STEP 1: Patients must not have received any prior therapy for their central nervous system (CNS) malignancy except for surgery and steroid medications.

- STEP 1: Patients who are currently receiving another investigational drug are not eligible.

- STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible.

- STEP 1: Patients >=18 years of age who have H3 K27M-wild type HGG.

- STEP 1: Patients who have an uncontrolled infection.

- STEP 1: Patients who have received a prior solid organ transplantation.

- STEP 1: Patients with grade > 1 extrapyramidal movement disorder.

- STEP 1: Patients with known macular degeneration, uncontrolled glaucoma, or cataracts.

- STEP 1: Patients with metastatic disease are not eligible; MRI of spine with and without contrast must be performed if metastatic disease is suspected by the treating physician.

- STEP 1: Patients with gliomatosis cerebri type 1 or 2 are not eligible, with the exception of H3 K27M-mutant bithalamic tumors.

- STEP 1: Patients who are not able to receive protocol specified radiation therapy.

- STEP 1: - Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.

- Lactating females are not eligible unless they have agreed not to breastfeed their infants.

It is not known whether selinexor is excreted in human milk.

- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.

- Sexually active patients of reproductive potential are not eligible unless they have agreed to use two effective methods of birth control (including a medically accepted barrier method of contraception, e.g., male or female condom) for the duration of their study participation and for 90 days after the last dose of selinexor.

Abstinence is an acceptable method of birth control.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05099003
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Adam L Green
Principal Investigator Affiliation	Children's Oncology Group
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	Australia, Canada, New Zealand, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Glioblastoma, Glioblastoma, Not Otherwise Specified, Malignant Glioma

Additional Details

PRIMARY OBJECTIVES:

I. To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).

(Dose-finding phase/phase I)

II. To estimate the event-free survival (EFS) distribution for diffuse midline glioma (DMG)/HGG patients and overall survival (OS) distribution for DIPG patients associated with selinexor plus RT, followed by selinexor in patients with newly diagnosed HGG (H3 K27M mutant DMG or H3 K27-wild type HGG) or DIPG, and to compare those outcomes to historical controls.

(Efficacy phase/phase II) EXPLORATORY OBJECTIVE:

I. To bank tumor specimens and body fluids (blood and cerebrospinal fluid) for future studies.

OUTLINE: This is a phase I dose-escalation study of selinexor followed by a phase II study. CHEMORADIOTHERAPY: Patients receive standard of care radiation therapy 5 days per week for 5-7 weeks. Starting on day 4 or 5 of radiation therapy, patients receive selinexor orally (PO) on days 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. After a 2-week rest period, patients proceed to Maintenance. Patients undergo a magnetic resonance imaging (MRI) and may undergo a biopsy during screening. MAINTENANCE: Patients receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 24 cycles of maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients undergo a MRI on study and during follow-up. After completion of study treatment, patients are followed every 3 months for year 1 (i.e., 3, 6, 9, 12 months), then every 6 months for years 2-3 (i.e., 18, 24, 30, 36 months), and finally once yearly for years 4-5 of this study.

Arms & Interventions

Arms

Experimental: Treatment (selinexor and radiation therapy)

CHEMORADIOTHERAPY: Patients receive standard of care radiation therapy 5 days per week for 5-7 weeks. Starting on day 4 or 5 of radiation therapy, patients receive selinexor PO on 1, 8, 15, 22, 29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity. After a 2-week rest period, patients proceed to Maintenance. Patients undergo a MRI and may undergo a biopsy during screening. MAINTENANCE: Patients receive selinexor PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days for up to 24 cycles of maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients undergo a MRI on study and during follow-up.

Interventions

Procedure: - Biopsy

Undergo a biopsy

Procedure: - Magnetic Resonance Imaging

Undergo a MRI

Radiation: - Radiation Therapy

Undergo radiation therapy

Drug: - Selinexor

Given orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Alabama, Birmingham, Alabama

Status

Recruiting

Address

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Site Contact

Site Public Contact

[email protected]

205-638-9285

Banner Children's at Desert, Mesa, Arizona

Status

Recruiting

Address

Banner Children's at Desert

Mesa, Arizona, 85202

Site Contact

Site Public Contact

480-412-3100

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Site Contact

Site Public Contact

501-364-7373

Loma Linda University Medical Center, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Site Contact

Site Public Contact

909-558-4050

Long Beach, California

Status

Recruiting

Address

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

Site Contact

Site Public Contact

562-933-5600

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

Site Public Contact

323-361-4110

UCSF Benioff Children's Hospital Oakland, Oakland, California

Status

Recruiting

Address

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

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Site Public Contact

[email protected]

510-428-3264

Kaiser Permanente-Oakland, Oakland, California

Status

Recruiting

Address

Kaiser Permanente-Oakland

Oakland, California, 94611

Site Contact

Site Public Contact

[email protected]

877-642-4691

Children's Hospital of Orange County, Orange, California

Status

Recruiting

Address

Children's Hospital of Orange County

Orange, California, 92868

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Site Public Contact

[email protected]

714-509-8646

Palo Alto, California

Status

Recruiting

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

Site Contact

Site Public Contact

[email protected]

800-694-0012

Rady Children's Hospital - San Diego, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital - San Diego

San Diego, California, 92123

Site Contact

Site Public Contact

858-966-5934

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Suspended

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Site Public Contact

[email protected]

303-764-5056

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Site Contact

Site Public Contact

860-545-9981

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Alfred I duPont Hospital for Children, Wilmington, Delaware

Status

Recruiting

Address

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

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Site Public Contact

[email protected]

302-651-5572

Children's National Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Site Contact

Site Public Contact

[email protected]

202-476-2800

Fort Myers, Florida

Status

Recruiting

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Site Contact

Site Public Contact

[email protected]

239-343-5333

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

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Site Public Contact

[email protected]

302-651-5572

Miami Cancer Institute, Miami, Florida

Status

Recruiting

Address

Miami Cancer Institute

Miami, Florida, 33176

Site Contact

Site Public Contact

786-596-2000

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

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Site Public Contact

[email protected]

321-841-5357

Nemours Children's Hospital, Orlando, Florida

Status

Recruiting

Address

Nemours Children's Hospital

Orlando, Florida, 32827

Site Contact

Site Public Contact

[email protected]

302-651-5572

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

Status

Recruiting

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Site Contact

Site Public Contact

[email protected]

727-767-4784

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

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Site Public Contact

[email protected]

404-785-2025

Honolulu, Hawaii

Status

Recruiting

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

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Site Public Contact

808-983-6090

Saint Luke's Cancer Institute - Boise, Boise, Idaho

Status

Recruiting

Address

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Site Contact

Site Public Contact

[email protected]

208-381-2774

Chicago, Illinois

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Site Contact

Site Public Contact

[email protected]

773-702-8222

Saint Jude Midwest Affiliate, Peoria, Illinois

Status

Recruiting

Address

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Site Contact

Site Public Contact

888-226-4343

Riley Hospital for Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Site Contact

Site Public Contact

800-248-1199

Blank Children's Hospital, Des Moines, Iowa

Status

Recruiting

Address

Blank Children's Hospital

Des Moines, Iowa, 50309

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Site Public Contact

[email protected]

515-241-8912

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

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800-237-1225

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

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859-257-3379

Norton Children's Hospital, Louisville, Kentucky

Status

Recruiting

Address

Norton Children's Hospital

Louisville, Kentucky, 40202

Site Contact

Site Public Contact

[email protected]

502-629-5500

Children's Hospital New Orleans, New Orleans, Louisiana

Status

Recruiting

Address

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Site Contact

Site Public Contact

[email protected]

Eastern Maine Medical Center, Bangor, Maine

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor, Maine, 04401

Site Contact

Site Public Contact

207-973-4274

Maine Children's Cancer Program, Scarborough, Maine

Status

Recruiting

Address

Maine Children's Cancer Program

Scarborough, Maine, 04074

Site Contact

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[email protected]

207-396-7581

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Site Contact

Site Public Contact

[email protected]

410-955-8804

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Site Public Contact

877-442-3324

C S Mott Children's Hospital, Ann Arbor, Michigan

Status

Recruiting

Address

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Site Contact

Site Public Contact

800-865-1125

Children's Hospital of Michigan, Detroit, Michigan

Status

Recruiting

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201

Site Contact

Site Public Contact

[email protected]

Grand Rapids, Michigan

Status

Recruiting

Address

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

Grand Rapids, Michigan, 49503

Site Contact

Site Public Contact

[email protected]

616-267-1925

Minneapolis, Minnesota

Status

Recruiting

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Site Contact

Site Public Contact

[email protected]

612-813-5913

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

Site Contact

Site Public Contact

612-624-2620

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Site Contact

Site Public Contact

601-815-6700

Children's Mercy Hospitals and Clinics, Kansas City, Missouri

Status

Recruiting

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Site Contact

Site Public Contact

[email protected]

816-302-6808

Saint Louis, Missouri

Status

Recruiting

Address

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

Site Contact

Site Public Contact

314-268-4000

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Mercy Hospital Saint Louis, Saint Louis, Missouri

Status

Recruiting

Address

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

Site Contact

Site Public Contact

314-251-7066

Omaha, Nebraska

Status

Recruiting

Address

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-955-3949

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Site Public Contact

[email protected]

402-559-6941

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Site Contact

Site Public Contact

201-996-2879

Morristown Medical Center, Morristown, New Jersey

Status

Recruiting

Address

Morristown Medical Center

Morristown, New Jersey, 07960

Site Contact

Site Public Contact

973-971-5900

New Brunswick, New Jersey

Status

Recruiting

Address

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

New Brunswick, New Jersey, 08903

Site Contact

Site Public Contact

732-235-8675

Newark Beth Israel Medical Center, Newark, New Jersey

Status

Recruiting

Address

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

Site Contact

Site Public Contact

[email protected]

973-926-7230

Saint Joseph's Regional Medical Center, Paterson, New Jersey

Status

Recruiting

Address

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

Site Contact

Site Public Contact

[email protected]

973-754-2207

Albany Medical Center, Albany, New York

Status

Recruiting

Address

Albany Medical Center

Albany, New York, 12208

Site Contact

Site Public Contact

518-262-5513

Montefiore Medical Center - Moses Campus, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

Site Contact

Site Public Contact

[email protected]

718-379-6866

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Site Public Contact

[email protected]

800-767-9355

New Hyde Park, New York

Status

Recruiting

Address

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

New Hyde Park, New York, 11040

Site Contact

Site Public Contact

718-470-3460

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Site Public Contact

212-639-7592

Syracuse, New York

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse, New York, 13210

Site Contact

Site Public Contact

315-464-5476

Charlotte, North Carolina

Status

Recruiting

Address

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204

Site Contact

Site Public Contact

[email protected]

980-201-6360

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Site Contact

Site Public Contact

336-713-6771

Sanford Broadway Medical Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Site Contact

Site Public Contact

[email protected]

701-323-5760

Akron, Ohio

Status

Recruiting

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Site Contact

Site Public Contact

330-543-3193

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Site Public Contact

[email protected]

513-636-2799

Rainbow Babies and Childrens Hospital, Cleveland, Ohio

Status

Recruiting

Address

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Site Contact

Site Public Contact

216-844-5437

Nationwide Children's Hospital, Columbus, Ohio

Status

Recruiting

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Site Contact

Site Public Contact

[email protected]

614-722-6039

Toledo, Ohio

Status

Suspended

Address

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Legacy Emanuel Children's Hospital, Portland, Oregon

Status

Recruiting

Address

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Site Contact

Site Public Contact

503-413-2560

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Site Public Contact

[email protected]

267-425-5544

Philadelphia, Pennsylvania

Status

Recruiting

Address

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

Site Contact

Site Public Contact

215-427-8991

Pittsburgh, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Site Contact

Site Public Contact

[email protected]

412-692-8570

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Site Contact

Site Public Contact

401-444-1488

Prisma Health Richland Hospital, Columbia, South Carolina

Status

Recruiting

Address

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

Site Contact

Site Public Contact

864-241-6251

BI-LO Charities Children's Cancer Center, Greenville, South Carolina

Status

Recruiting

Address

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Site Contact

Site Public Contact

864-241-6251

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Site Contact

Site Public Contact

[email protected]

605-312-3320

Saint Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Site Public Contact

[email protected]

888-226-4343

Nashville, Tennessee

Status

Recruiting

Address

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

Site Contact

Site Public Contact

615-342-1919

Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Site Contact

Site Public Contact

[email protected]

512-628-1902

Medical City Dallas Hospital, Dallas, Texas

Status

Recruiting

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Site Contact

Site Public Contact

972-566-5588

Dallas, Texas

Status

Recruiting

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Site Contact

Site Public Contact

[email protected]

214-648-7097

Cook Children's Medical Center, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Site Contact

Site Public Contact

[email protected]

682-885-2103

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

713-798-1354

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

877-632-6789

Children's Hospital of San Antonio, San Antonio, Texas

Status

Recruiting

Address

Children's Hospital of San Antonio

San Antonio, Texas, 78207

Site Contact

Site Public Contact

[email protected]

210-704-2894

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Site Contact

Site Public Contact

801-585-5270

Norfolk, Virginia

Status

Recruiting

Address

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Site Contact

Site Public Contact

[email protected]

757-668-7243

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Site Public Contact

866-987-2000

Spokane, Washington

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Site Contact

Site Public Contact

[email protected]

800-228-6618

Tacoma, Washington

Status

Recruiting

Address

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

Site Contact

Site Public Contact

[email protected]

253-403-1461

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

Site Contact

Site Public Contact

[email protected]

800-622-8922

Children's Hospital of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Site Public Contact

[email protected]

414-955-4727

International Sites

Royal Children's Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

Royal Children's Hospital

Parkville, Victoria, 3052

Site Contact

Site Public Contact

[email protected]

61 3 9345 5656

Perth Children's Hospital, Perth, Western Australia, Australia

Status

Recruiting

Address

Perth Children's Hospital

Perth, Western Australia, 6009

Site Contact

Site Public Contact

[email protected]

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

Site Contact

Site Public Contact

[email protected]

866-561-1026

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

Site Contact

Site Public Contact

[email protected]

902-470-8520

Montreal, Quebec, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5

Quebec, Canada

Status

Suspended

Address

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

Quebec, , G1V 4G2

Starship Children's Hospital, Grafton, Auckland, New Zealand

Status

Recruiting

Address

Starship Children's Hospital

Grafton, Auckland, 1145

Site Contact

Site Public Contact

0800 728 436

Christchurch Hospital, Christchurch, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch, , 8011

Site Contact

Site Public Contact

03 364 0640

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