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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 central 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) - As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
  • - 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.
  • - Note: As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
  • - 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 (Closed with Amendment #4) - As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
  • - 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) (Closed with Amendment #4) - As of February 14, 2025, stratum DIPG and stratum DMG have closed to accrual, and no patients will be enrolled on these strata after Amendment #4.
  • - 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/sex 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.

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. (STRATUM DIPG AND STRATUM DMG CLOSED TO ACCRUAL 02/14/2025) 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 Procedure

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 4049979, Alabama 4829764

Status

Recruiting

Address

Children's Hospital of Alabama

Birmingham 4049979, Alabama 4829764, 35233

Site Contact

Site Public Contact

[email protected]

205-638-9285

Banner Children's at Desert, Mesa 5304391, Arizona 5551752

Status

Recruiting

Address

Banner Children's at Desert

Mesa 5304391, Arizona 5551752, 85202

Site Contact

Site Public Contact

480-412-3100

Phoenix Childrens Hospital, Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix 5308655, Arizona 5551752, 85016

Site Contact

Site Public Contact

602-546-0920

Arkansas Children's Hospital, Little Rock 4119403, Arkansas 4099753

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock 4119403, Arkansas 4099753, 72202-3591

Site Contact

Site Public Contact

501-364-7373

Loma Linda University Medical Center, Loma Linda 5367696, California 5332921

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda 5367696, California 5332921, 92354

Site Contact

Site Public Contact

909-558-4050

Long Beach 5367929, California 5332921

Status

Recruiting

Address

Miller Children's and Women's Hospital Long Beach

Long Beach 5367929, California 5332921, 90806

Site Contact

Site Public Contact

562-933-5600

Children's Hospital Los Angeles, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles 5368361, California 5332921, 90027

Site Contact

Site Public Contact

323-361-4110

Cedars Sinai Medical Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles 5368361, California 5332921, 90048

Site Contact

Site Public Contact

310-423-8965

UCSF Benioff Children's Hospital Oakland, Oakland 5378538, California 5332921

Status

Recruiting

Address

UCSF Benioff Children's Hospital Oakland

Oakland 5378538, California 5332921, 94609

Site Contact

Site Public Contact

[email protected]

510-428-3264

Kaiser Permanente-Oakland, Oakland 5378538, California 5332921

Status

Recruiting

Address

Kaiser Permanente-Oakland

Oakland 5378538, California 5332921, 94611

Site Contact

Site Public Contact

[email protected]

877-642-4691

Children's Hospital of Orange County, Orange 5379513, California 5332921

Status

Recruiting

Address

Children's Hospital of Orange County

Orange 5379513, California 5332921, 92868

Site Contact

Site Public Contact

[email protected]

714-509-8646

Palo Alto 5380748, California 5332921

Status

Recruiting

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto 5380748, California 5332921, 94304

Site Contact

Site Public Contact

[email protected]

800-694-0012

Rady Children's Hospital - San Diego, San Diego 5391811, California 5332921

Status

Recruiting

Address

Rady Children's Hospital - San Diego

San Diego 5391811, California 5332921, 92123

Site Contact

Site Public Contact

858-966-5934

UCSF Medical Center-Mission Bay, San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF Medical Center-Mission Bay

San Francisco 5391959, California 5332921, 94158

Site Contact

Site Public Contact

[email protected]

877-827-3222

Children's Hospital Colorado, Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

Children's Hospital Colorado

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Site Public Contact

[email protected]

303-764-5056

Connecticut Children's Medical Center, Hartford 4835797, Connecticut 4831725

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford 4835797, Connecticut 4831725, 06106

Site Contact

Site Public Contact

860-545-9981

Yale University, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale University

New Haven 4839366, Connecticut 4831725, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Alfred I duPont Hospital for Children, Wilmington 4145381, Delaware 4142224

Status

Recruiting

Address

Alfred I duPont Hospital for Children

Wilmington 4145381, Delaware 4142224, 19803

Site Contact

Site Public Contact

[email protected]

302-651-5572

Children's National Medical Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Recruiting

Address

Children's National Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20010

Site Contact

Site Public Contact

[email protected]

202-476-2800

Fort Myers 4155995, Florida 4155751

Status

Recruiting

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers 4155995, Florida 4155751, 33908

Site Contact

Site Public Contact

[email protected]

239-343-5333

Nemours Children's Clinic-Jacksonville, Jacksonville 4160021, Florida 4155751

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville 4160021, Florida 4155751, 32207

Site Contact

Site Public Contact

[email protected]

302-651-5572

Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami 4164138, Florida 4155751, 33136

Site Contact

Site Public Contact

305-243-2647

Miami Cancer Institute, Miami 4164138, Florida 4155751

Status

Active, not recruiting

Address

Miami Cancer Institute

Miami 4164138, Florida 4155751, 33176

Arnold Palmer Hospital for Children, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando 4167147, Florida 4155751, 32806

Site Contact

Site Public Contact

[email protected]

321-841-5357

Nemours Children's Hospital, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Nemours Children's Hospital

Orlando 4167147, Florida 4155751, 32827

Site Contact

Site Public Contact

[email protected]

302-651-5572

Johns Hopkins All Children's Hospital, St. Petersburg 4171563, Florida 4155751

Status

Recruiting

Address

Johns Hopkins All Children's Hospital

St. Petersburg 4171563, Florida 4155751, 33701

Site Contact

Site Public Contact

[email protected]

727-767-4784

Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta 4180439, Georgia 4197000, 30329

Site Contact

Site Public Contact

[email protected]

404-785-0232

Honolulu 5856195, Hawaii 5855797

Status

Recruiting

Address

Kapiolani Medical Center for Women and Children

Honolulu 5856195, Hawaii 5855797, 96826

Site Contact

Site Public Contact

808-983-6090

Saint Luke's Cancer Institute - Boise, Boise 5586437, Idaho 5596512

Status

Recruiting

Address

Saint Luke's Cancer Institute - Boise

Boise 5586437, Idaho 5596512, 83712

Site Contact

Site Public Contact

[email protected]

208-381-2774

Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center

Chicago 4887398, Illinois 4896861, 60637

Site Contact

Site Public Contact

[email protected]

773-702-8222

Saint Jude Midwest Affiliate, Peoria 4905687, Illinois 4896861

Status

Recruiting

Address

Saint Jude Midwest Affiliate

Peoria 4905687, Illinois 4896861, 61637

Site Contact

Site Public Contact

888-226-4343

Riley Hospital for Children, Indianapolis 4259418, Indiana 4921868

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis 4259418, Indiana 4921868, 46202

Site Contact

Site Public Contact

800-248-1199

Blank Children's Hospital, Des Moines 4853828, Iowa 4862182

Status

Recruiting

Address

Blank Children's Hospital

Des Moines 4853828, Iowa 4862182, 50309

Site Contact

Site Public Contact

[email protected]

515-241-8912

Iowa City 4862034, Iowa 4862182

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City 4862034, Iowa 4862182, 52242

Site Contact

Site Public Contact

800-237-1225

Lexington 4297983, Kentucky 6254925

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington 4297983, Kentucky 6254925, 40536

Site Contact

Site Public Contact

859-257-3379

Norton Children's Hospital, Louisville 4299276, Kentucky 6254925

Status

Recruiting

Address

Norton Children's Hospital

Louisville 4299276, Kentucky 6254925, 40202

Site Contact

Site Public Contact

[email protected]

502-629-5500

Children's Hospital New Orleans, New Orleans 4335045, Louisiana 4331987

Status

Recruiting

Address

Children's Hospital New Orleans

New Orleans 4335045, Louisiana 4331987, 70118

Site Contact

Site Public Contact

504-894-5377

Eastern Maine Medical Center, Bangor 4957280, Maine 4971068

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor 4957280, Maine 4971068, 04401

Site Contact

Site Public Contact

207-973-4274

Maine Children's Cancer Program, Scarborough 4977882, Maine 4971068

Status

Recruiting

Address

Maine Children's Cancer Program

Scarborough 4977882, Maine 4971068, 04074

Site Contact

Site Public Contact

[email protected]

207-396-8670

Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore 4347778, Maryland 4361885, 21287

Site Contact

Site Public Contact

[email protected]

410-955-8804

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

Site Public Contact

877-442-3324

C S Mott Children's Hospital, Ann Arbor 4984247, Michigan 5001836

Status

Recruiting

Address

C S Mott Children's Hospital

Ann Arbor 4984247, Michigan 5001836, 48109

Site Contact

Site Public Contact

800-865-1125

Children's Hospital of Michigan, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Children's Hospital of Michigan

Detroit 4990729, Michigan 5001836, 48201

Site Contact

Site Public Contact

[email protected]

Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

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

Grand Rapids 4994358, Michigan 5001836, 49503

Site Contact

Site Public Contact

[email protected]

616-391-1230

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis 5037649, Minnesota 5037779, 55404

Site Contact

Site Public Contact

[email protected]

612-813-5913

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

University of Minnesota/Masonic Cancer Center

Minneapolis 5037649, Minnesota 5037779, 55455

Site Contact

Site Public Contact

612-624-2620

University of Mississippi Medical Center, Jackson 4431410, Mississippi 4436296

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson 4431410, Mississippi 4436296, 39216

Site Contact

Site Public Contact

601-815-6700

Children's Mercy Hospitals and Clinics, Kansas City 4393217, Missouri 4398678

Status

Recruiting

Address

Children's Mercy Hospitals and Clinics

Kansas City 4393217, Missouri 4398678, 64108

Site Contact

Site Public Contact

[email protected]

816-302-6808

St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Cardinal Glennon Children's Medical Center

St Louis 4407066, Missouri 4398678, 63104

Site Contact

Site Public Contact

314-268-4000

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Mercy Hospital Saint Louis, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Mercy Hospital Saint Louis

St Louis 4407066, Missouri 4398678, 63141

Site Contact

Site Public Contact

314-251-7066

Omaha 5074472, Nebraska 5073708

Status

Recruiting

Address

Children's Hospital and Medical Center of Omaha

Omaha 5074472, Nebraska 5073708, 68114

Site Contact

Site Public Contact

402-955-3949

University of Nebraska Medical Center, Omaha 5074472, Nebraska 5073708

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha 5074472, Nebraska 5073708, 68198

Site Contact

Site Public Contact

[email protected]

402-559-6941

Hackensack University Medical Center, Hackensack 5098706, New Jersey 5101760

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack 5098706, New Jersey 5101760, 07601

Site Contact

Site Public Contact

551-996-2897

Morristown Medical Center, Morristown 5101427, New Jersey 5101760

Status

Recruiting

Address

Morristown Medical Center

Morristown 5101427, New Jersey 5101760, 07960

Site Contact

Site Public Contact

973-971-5900

New Brunswick 5101717, New Jersey 5101760

Status

Suspended

Address

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

New Brunswick 5101717, New Jersey 5101760, 08903

Newark Beth Israel Medical Center, Newark 5101798, New Jersey 5101760

Status

Recruiting

Address

Newark Beth Israel Medical Center

Newark 5101798, New Jersey 5101760, 07112

Site Contact

Site Public Contact

[email protected]

973-926-7230

Saint Joseph's Regional Medical Center, Paterson 5102466, New Jersey 5101760

Status

Recruiting

Address

Saint Joseph's Regional Medical Center

Paterson 5102466, New Jersey 5101760, 07503

Site Contact

Site Public Contact

[email protected]

973-754-2207

Albany Medical Center, Albany 5106834, New York 5128638

Status

Recruiting

Address

Albany Medical Center

Albany 5106834, New York 5128638, 12208

Site Contact

Site Public Contact

518-262-5513

Roswell Park Cancer Institute, Buffalo 5110629, New York 5128638

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo 5110629, New York 5128638, 14263

Site Contact

Site Public Contact

[email protected]

800-767-9355

New Hyde Park 5128514, New York 5128638

Status

Recruiting

Address

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

New Hyde Park 5128514, New York 5128638, 11040

Site Contact

Site Public Contact

718-470-3460

New York 5128581, New York 5128638

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York 5128581, New York 5128638, 10016

Site Contact

Site Public Contact

[email protected]

New York 5128581, New York 5128638

Status

Recruiting

Address

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

New York 5128581, New York 5128638, 10032

Site Contact

Site Public Contact

[email protected]

212-342-5162

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Site Contact

Site Public Contact

212-639-7592

Syracuse 5140405, New York 5128638

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse 5140405, New York 5128638, 13210

Site Contact

Site Public Contact

315-464-5476

Montefiore Medical Center - Moses Campus, The Bronx 5110266, New York 5128638

Status

Recruiting

Address

Montefiore Medical Center - Moses Campus

The Bronx 5110266, New York 5128638, 10467

Site Contact

Site Public Contact

[email protected]

718-379-6866

Charlotte 4460243, North Carolina 4482348

Status

Recruiting

Address

Novant Health Presbyterian Medical Center

Charlotte 4460243, North Carolina 4482348, 28204

Site Contact

Site Public Contact

[email protected]

980-201-6360

East Carolina University, Greenville 4469160, North Carolina 4482348

Status

Recruiting

Address

East Carolina University

Greenville 4469160, North Carolina 4482348, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Wake Forest University Health Sciences

Winston-Salem 4499612, North Carolina 4482348, 27157

Site Contact

Site Public Contact

336-713-6771

Sanford Broadway Medical Center, Fargo 5059163, North Dakota 5690763

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo 5059163, North Dakota 5690763, 58122

Site Contact

Site Public Contact

[email protected]

701-323-5760

Akron 5145476, Ohio 5165418

Status

Recruiting

Address

Children's Hospital Medical Center of Akron

Akron 5145476, Ohio 5165418, 44308

Site Contact

Site Public Contact

330-543-3193

Cincinnati 4508722, Ohio 5165418

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati 4508722, Ohio 5165418, 45229

Site Contact

Site Public Contact

[email protected]

513-636-2799

Rainbow Babies and Childrens Hospital, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Rainbow Babies and Childrens Hospital

Cleveland 5150529, Ohio 5165418, 44106

Site Contact

Site Public Contact

216-844-5437

Nationwide Children's Hospital, Columbus 4509177, Ohio 5165418

Status

Recruiting

Address

Nationwide Children's Hospital

Columbus 4509177, Ohio 5165418, 43205

Site Contact

Site Public Contact

[email protected]

614-722-6039

Dayton Children's Hospital, Dayton 4509884, Ohio 5165418

Status

Recruiting

Address

Dayton Children's Hospital

Dayton 4509884, Ohio 5165418, 45404

Site Contact

Site Public Contact

800-228-4055

Toledo 5174035, Ohio 5165418

Status

Recruiting

Address

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo 5174035, Ohio 5165418, 43606

Site Contact

Site Public Contact

[email protected]

419-824-1842

Oklahoma City 4544349, Oklahoma 4544379

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Legacy Emanuel Children's Hospital, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Legacy Emanuel Children's Hospital

Portland 5746545, Oregon 5744337, 97227

Site Contact

Site Public Contact

503-413-2560

Oregon Health and Science University, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Oregon Health and Science University

Portland 5746545, Oregon 5744337, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Geisinger Medical Center, Danville 5186327, Pennsylvania 6254927

Status

Recruiting

Address

Geisinger Medical Center

Danville 5186327, Pennsylvania 6254927, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

Children's Hospital of Philadelphia, Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Site Public Contact

[email protected]

267-425-5544

Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Saint Christopher's Hospital for Children

Philadelphia 4560349, Pennsylvania 6254927, 19134

Site Contact

Site Public Contact

215-427-8991

Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh 5206379, Pennsylvania 6254927, 15224

Site Contact

Site Public Contact

[email protected]

412-692-8570

Rhode Island Hospital, Providence 5224151, Rhode Island 5224323

Status

Recruiting

Address

Rhode Island Hospital

Providence 5224151, Rhode Island 5224323, 02903

Site Contact

Site Public Contact

401-444-1488

Prisma Health Richland Hospital, Columbia 4575352, South Carolina 4597040

Status

Recruiting

Address

Prisma Health Richland Hospital

Columbia 4575352, South Carolina 4597040, 29203

Site Contact

Site Public Contact

[email protected]

864-522-4317

BI-LO Charities Children's Cancer Center, Greenville 4580543, South Carolina 4597040

Status

Recruiting

Address

BI-LO Charities Children's Cancer Center

Greenville 4580543, South Carolina 4597040, 29605

Site Contact

Site Public Contact

[email protected]

864-522-4317

Sanford USD Medical Center - Sioux Falls, Sioux Falls 5231851, South Dakota 5769223

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls 5231851, South Dakota 5769223, 57117-5134

Site Contact

Site Public Contact

[email protected]

605-312-3320

East Tennessee Childrens Hospital, Knoxville 4634946, Tennessee 4662168

Status

Recruiting

Address

East Tennessee Childrens Hospital

Knoxville 4634946, Tennessee 4662168, 37916

Site Contact

Site Public Contact

865-541-8266

Saint Jude Children's Research Hospital, Memphis 4641239, Tennessee 4662168

Status

Recruiting

Address

Saint Jude Children's Research Hospital

Memphis 4641239, Tennessee 4662168, 38105

Site Contact

Site Public Contact

[email protected]

888-226-4343

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

The Children's Hospital at TriStar Centennial

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

Site Public Contact

615-342-1919

Austin 4671654, Texas 4736286

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin 4671654, Texas 4736286, 78723

Site Contact

Site Public Contact

[email protected]

512-628-1902

Medical City Dallas Hospital, Dallas 4684888, Texas 4736286

Status

Recruiting

Address

Medical City Dallas Hospital

Dallas 4684888, Texas 4736286, 75230

Site Contact

Site Public Contact

972-566-5588

Dallas 4684888, Texas 4736286

Status

Recruiting

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas 4684888, Texas 4736286, 75390

Site Contact

Site Public Contact

[email protected]

214-648-7097

El Paso Children's Hospital, El Paso 5520993, Texas 4736286

Status

Recruiting

Address

El Paso Children's Hospital

El Paso 5520993, Texas 4736286, 79905

Site Contact

Site Public Contact

[email protected]

915-298-5444

Cook Children's Medical Center, Fort Worth 4691930, Texas 4736286

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth 4691930, Texas 4736286, 76104

Site Contact

Site Public Contact

[email protected]

682-885-2103

Houston 4699066, Texas 4736286

Status

Recruiting

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Site Public Contact

[email protected]

713-798-1354

M D Anderson Cancer Center, Houston 4699066, Texas 4736286

Status

Recruiting

Address

M D Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Site Public Contact

[email protected]

877-632-6789

Children's Hospital of San Antonio, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

Children's Hospital of San Antonio

San Antonio 4726206, Texas 4736286, 78207

Site Contact

Site Public Contact

[email protected]

210-704-2894

San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio 4726206, Texas 4736286, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Primary Children's Hospital, Salt Lake City 5780993, Utah 5549030

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City 5780993, Utah 5549030, 84113

Site Contact

Site Public Contact

801-585-5270

University of Virginia Cancer Center, Charlottesville 4752031, Virginia 6254928

Status

Recruiting

Address

University of Virginia Cancer Center

Charlottesville 4752031, Virginia 6254928, 22908

Site Contact

Site Public Contact

[email protected]

434-243-6303

Norfolk 4776222, Virginia 6254928

Status

Recruiting

Address

Children's Hospital of The King's Daughters

Norfolk 4776222, Virginia 6254928, 23507

Site Contact

Site Public Contact

[email protected]

757-668-7243

Seattle Children's Hospital, Seattle 5809844, Washington 5815135

Status

Recruiting

Address

Seattle Children's Hospital

Seattle 5809844, Washington 5815135, 98105

Site Contact

Site Public Contact

866-987-2000

Spokane 5811696, Washington 5815135

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane 5811696, Washington 5815135, 99204

Site Contact

Site Public Contact

[email protected]

800-228-6618

Tacoma 5812944, Washington 5815135

Status

Recruiting

Address

Mary Bridge Children's Hospital and Health Center

Tacoma 5812944, Washington 5815135, 98405

Site Contact

Site Public Contact

[email protected]

253-403-1461

Madison 5261457, Wisconsin 5279468

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center - University Hospital

Madison 5261457, Wisconsin 5279468, 53792

Site Contact

Site Public Contact

[email protected]

800-622-8922

Children's Hospital of Wisconsin, Milwaukee 5263045, Wisconsin 5279468

Status

Recruiting

Address

Children's Hospital of Wisconsin

Milwaukee 5263045, Wisconsin 5279468, 53226

Site Contact

Site Public Contact

[email protected]

414-955-4727

International Sites

Sydney Children's Hospital, Randwick 2208285, New South Wales 2155400, Australia

Status

Suspended

Address

Sydney Children's Hospital

Randwick 2208285, New South Wales 2155400, 2031

The Children's Hospital at Westmead, Westmead 2143973, New South Wales 2155400, Australia

Status

Recruiting

Address

The Children's Hospital at Westmead

Westmead 2143973, New South Wales 2155400, 2145

Site Contact

Site Public Contact

61-2-9845 1400

Queensland Children's Hospital, South Brisbane 2207259, Queensland 2152274, Australia

Status

Suspended

Address

Queensland Children's Hospital

South Brisbane 2207259, Queensland 2152274, 4101

Royal Children's Hospital, Parkville 2153770, Victoria 2145234, Australia

Status

Recruiting

Address

Royal Children's Hospital

Parkville 2153770, Victoria 2145234, 3052

Site Contact

Site Public Contact

[email protected]

61 3 9345 5656

Perth Children's Hospital, Perth 2063523, Western Australia 2058645, Australia

Status

Suspended

Address

Perth Children's Hospital

Perth 2063523, Western Australia 2058645, 6009

University of Alberta Hospital, Edmonton 5946768, Alberta 5883102, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton 5946768, Alberta 5883102, T6G 2B7

Site Contact

Site Public Contact

[email protected]

780-407-8798

British Columbia Children's Hospital, Vancouver 6173331, British Columbia 5909050, Canada

Status

Suspended

Address

British Columbia Children's Hospital

Vancouver 6173331, British Columbia 5909050, V6H 3V4

CancerCare Manitoba, Winnipeg 6183235, Manitoba 6065171, Canada

Status

Recruiting

Address

CancerCare Manitoba

Winnipeg 6183235, Manitoba 6065171, R3E 0V9

Site Contact

Site Public Contact

[email protected]

866-561-1026

IWK Health Centre, Halifax 6324729, Nova Scotia 6091530, Canada

Status

Suspended

Address

IWK Health Centre

Halifax 6324729, Nova Scotia 6091530, B3K 6R8

Hospital for Sick Children, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto 6167865, Ontario 6093943, M5G 1X8

Site Contact

Site Public Contact

[email protected]

416-813-7654

Montreal 6077243, Quebec 6115047, Canada

Status

Suspended

Address

The Montreal Children's Hospital of the MUHC

Montreal 6077243, Quebec 6115047, H3H 1P3

Montreal 6077243, Quebec 6115047, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal 6077243, Quebec 6115047, H3T 1C5

Sherbrooke 6146143, Quebec 6115047, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke 6146143, Quebec 6115047, J1H 5N4

Jim Pattison Children's Hospital, Saskatoon 6141256, Saskatchewan 6141242, Canada

Status

Suspended

Address

Jim Pattison Children's Hospital

Saskatoon 6141256, Saskatchewan 6141242, S7N 0W8

Québec 6325494, Canada

Status

Suspended

Address

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

Québec 6325494, , G1V 4G2

Starship Children's Hospital, Grafton 6232401, Auckland 2193734, New Zealand

Status

Recruiting

Address

Starship Children's Hospital

Grafton 6232401, Auckland 2193734, 1145

Site Contact

Site Public Contact

0800 728 436

Christchurch Hospital, Christchurch 2192362, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch 2192362, , 8011

Site Contact

Site Public Contact

03 364 0640