Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Study Purpose

This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.

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 ELIGIBILITY SCREENING: Patients must be =< 25 years of age at the time of enrollment on APEC14B1 Part A CNS/HGG pre-enrollment eligibility screening.

- Note: This required age range applies to the pre-enrollment eligibility screening for all HGG patients.

Individual treatment protocols may have different age criteria.

- PRE-ENROLLMENT ELIGIBILITY SCREENING: Patient is suspected of having localized newly-diagnosed HGG, excluding metastatic disease.

- PRE-ENROLLMENT ELIGIBILITY SCREENING: Patient and/or their parents or legal guardians have signed informed consent for eligibility screening on APEC14B1 Part A.

- PRE-ENROLLMENT ELIGIBILITY SCREENING: The specimens obtained at the time of diagnostic biopsy or surgery must be submitted through APEC14B1 as soon as possible (ASAP), preferably within 5 calendar days of the procedure.

- Please note: See the APEC14B1 Manual of Procedures for a full list of detailed instructions for submitting required materials and for shipping details.

- Patients must be >= 3 years and =< 25 years of age at the time of enrollment.

- Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1.

- Newly diagnosed high-grade glioma with BRAF^V600-mutation.

- Results for H3 K27M by immunohistochemistry (IHC) or sequencing.

- Histologically confirmed high-grade glioma (World Health Organization [WHO] grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, not otherwise specified (NOS).

- Patients must have had histologic verification of a high-grade glioma diagnosis.

CSF cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.

- A pre- and post-operative brain MRI with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment.

The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.

- 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.

- 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 [RBC] transfusions) (within 7 days prior to enrollment).

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 (within 7 days prior to enrollment) or.

- A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): - Age 3 to < 6 years (Male 0.8 mg/dL, Female 0.8 mg/dL) - Age 6 to < 10 years (Male 1 mg/dL, Female 1 mg/dL) - Age 10 to < 13 years (Male 1.2 mg/dL, Female 1.2 mg/dL) - Age 13 to < 16 years (Male 1.5 mg/dL, Female 1.4 mg/dL) - Age >= 16 years (Male 1.7 mg/dL, Female 1.4 mg/dL) - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and.

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment).

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

- Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.

- All patients and/or their parents or legal guardians must sign a written informed consent.

- Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (day 0).

If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.

Exclusion Criteria:

- Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.

- Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.

- Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.

- Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.

- Patients with a history of a malignancy with confirmed activating RAS mutation.

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.

- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.

- Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.

- History of hepatitis B virus, or hepatitis C virus infection (patients with laboratory evidence of cleared hepatitis B virus and/or hepatitis C virus may be enrolled).

- History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: - Recent myocardial infarction (within the last 6 months); - Uncontrolled congestive heart failure; - Unstable angina (within last 6 months); - Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular [AV] block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment; - Coronary angioplasty or stenting (within last 6 months); - Intra-cardiac defibrillators; - Abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram.

- Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).

- Patients with presence of interstitial lung disease or pneumonitis.

- 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 for the duration of the study and for 4 months following discontinuation of study therapy.

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

- Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy.

Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy. Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.

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.	NCT03919071
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 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.	Rishi R Lulla
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	Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified, Anaplastic Ganglioglioma, Anaplastic Pleomorphic Xanthoastrocytoma, Glioblastoma, Malignant Glioma, WHO Grade 3 Glioma

Additional Details

PRIMARY OBJECTIVE:

I. To estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAF^V600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib mesylate (dabrafenib) and trametinib dimethyl sulfoxide (trametinib) and to compare this EFS to contemporary historical controls.

SECONDARY OBJECTIVES:

I. To describe the overall survival (OS) distribution for newly-diagnosed patients with BRAF^V600-mutant HGG without H3 K27M mutations excluding aPXA and aGG treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib.

II. To describe the EFS and overall survival (OS) distribution for newly-diagnosed patients with BRAF^V600E-mutant aPXA and aGG without H3 K27M mutations treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib.

III. To describe the EFS and overall survival (OS) distribution for newly-diagnosed patients with BRAF^V600E-mutant HGG including aPXA and aGG with H3 K27M mutations treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib.

IV. To define and evaluate the toxicities of combination therapy with dabrafenib and trametinib after radiation therapy in newly-diagnosed patients with HGG.

EXPLORATORY OBJECTIVE:

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

OUTLINE: Patients undergo standardized local radiation therapy (RT) 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate orally (PO) twice daily (BID) and trametinib dimethyl sulfoxide PO once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a magnetic resonance imaging (MRI) at baseline, on day 1 of cycles 1, 3, 5, 7, 11, 14, 17, 20, and 23 while on treatment, then at time of relapse, every 3 months for year 1, every 4 months for year 3, every 6 months for year 3, and annually for years 4-5. Patients may also undergo lumbar puncture for cerebral spinal fluid (CSF) testing during treatment. Patients also undergo collection of blood on study. After completion of study treatment, patients are followed up at disease relapse, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then annually for years 4-5.

Arms & Interventions

Arms

Experimental: Treatment (radiation therapy, dabrafenib, trametinib)

Patients undergo standardized local RT 5 days a week (Monday-Friday) for 6-7 weeks. Four weeks after completion of RT, patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline, on day 1 of cycles 1, 3, 5, 7, 11, 14, 17, 20, and 23 while on treatment, then at time of relapse, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, and annually for years 4-5. Patients may also undergo lumbar puncture for CSF testing during treatment. Patients also undergo collection of blood on study.

Interventions

Procedure: - Biospecimen Collection

Undergo collection of blood

Drug: - Dabrafenib Mesylate

Given PO

Procedure: - Lumbar Puncture

Undergo lumbar puncture

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Radiation: - Radiation Therapy

Undergo RT

Drug: - Trametinib Dimethyl Sulfoxide

Given PO

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

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Site Contact

Site Public Contact

602-546-0920

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

Kaiser Permanente Downey Medical Center, Downey, California

Status

Recruiting

Address

Kaiser Permanente Downey Medical Center

Downey, California, 90242

Site Contact

Site Public Contact

626-564-3455

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

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Site Public Contact

310-423-8965

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

Site Contact

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

Sacramento, California

Status

Active, not recruiting

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Recruiting

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Site Contact

Site Public Contact

[email protected]

877-827-3222

Torrance, California

Status

Active, not recruiting

Address

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

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

Site Contact

Site Public Contact

[email protected]

302-651-5572

MedStar Georgetown University Hospital, Washington, District of Columbia

Status

Active, not recruiting

Address

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

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

Gainesville, Florida

Status

Active, not recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Hollywood, Florida

Status

Recruiting

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Site Contact

Site Public Contact

[email protected]

954-265-1847

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Site Contact

Site Public Contact

[email protected]

302-651-5572

Miami, Florida

Status

Recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Site Contact

Site Public Contact

305-243-2647

Nicklaus Children's Hospital, Miami, Florida

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Site Contact

Site Public Contact

888-624-2778

AdventHealth Orlando, Orlando, Florida

Status

Recruiting

Address

AdventHealth Orlando

Orlando, Florida, 32803

Site Contact

Site Public Contact

[email protected]

407-303-2090

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Site Contact

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

Tampa General Hospital, Tampa, Florida

Status

Recruiting

Address

Tampa General Hospital

Tampa, Florida, 33606

Site Contact

Site Public Contact

[email protected]

813-844-7829

Tampa, Florida

Status

Recruiting

Address

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

Tampa, Florida, 33607

Site Contact

Site Public Contact

[email protected]

813-357-0849

Saint Mary's Hospital, West Palm Beach, Florida

Status

Recruiting

Address

Saint Mary's Hospital

West Palm Beach, Florida, 33407

Site Contact

Site Public Contact

561-881-2815

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

Site Contact

Site Public Contact

[email protected]

404-785-2025

Savannah, Georgia

Status

Recruiting

Address

Memorial Health University Medical Center

Savannah, Georgia, 31404

Site Contact

Site Public Contact

[email protected]

912-350-7887

Honolulu, Hawaii

Status

Recruiting

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

Site Contact

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

Lurie Children's Hospital-Chicago, Chicago, Illinois

Status

Recruiting

Address

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

Site Contact

Site Public Contact

773-880-4562

University of Illinois, Chicago, Illinois

Status

Recruiting

Address

University of Illinois

Chicago, Illinois, 60612

Site Contact

Site Public Contact

312-355-3046

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

Indianapolis, Indiana

Status

Recruiting

Address

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Site Contact

Site Public Contact

[email protected]

317-338-2194

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Site Contact

Site Public Contact

800-237-1225

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

Site Public Contact

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]

Ochsner Medical Center Jefferson, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Site Contact

Site Public Contact

[email protected]

504-842-8084

Eastern Maine Medical Center, Bangor, Maine

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor, Maine, 04401

Site Contact

Site Public Contact

207-973-4274

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

Bethesda, Maryland

Status

Recruiting

Address

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

Site Contact

Site Public Contact

301-319-2100

Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

Site Public Contact

877-726-5130

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

Bronson Methodist Hospital, Kalamazoo, Michigan

Status

Recruiting

Address

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

[email protected]

616-391-1230

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Children's Hospital-Royal Oak

Royal Oak, Michigan, 48073

Site Contact

Site Public Contact

248-551-7695

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

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

855-776-0015

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

University of New Mexico Cancer Center, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

Site Contact

Site Public Contact

[email protected]

505-925-0348

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

New York, New York

Status

Recruiting

Address

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

New York, New York, 10032

Site Contact

Site Public Contact

[email protected]

212-342-5162

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

Mission Hospital, Asheville, North Carolina

Status

Recruiting

Address

Mission Hospital

Asheville, North Carolina, 28801

Site Contact

Site Public Contact

[email protected]

828-213-7055

Charlotte, North Carolina

Status

Recruiting

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Site Contact

Site Public Contact

800-804-9376

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

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Site Public Contact

[email protected]

866-223-8100

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

Dayton Children's Hospital, Dayton, Ohio

Status

Recruiting

Address

Dayton Children's Hospital

Dayton, Ohio, 45404

Site Contact

Site Public Contact

800-228-4055

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

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania

Status

Recruiting

Address

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

Site Contact

Site Public Contact

[email protected]

610-402-9543

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Site Contact

Site Public Contact

717-531-6012

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

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

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Site Public Contact

[email protected]

843-792-9321

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

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Recruiting

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Site Contact

Site Public Contact

865-541-8266

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

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Site Public Contact

800-811-8480

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

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

Scott and White Memorial Hospital, Temple, Texas

Status

Recruiting

Address

Scott and White Memorial Hospital

Temple, Texas, 76508

Site Contact

Site Public Contact

254-724-5407

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

University of Virginia Cancer Center, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

Site Contact

Site Public Contact

[email protected]

434-243-6303

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

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin

Status

Recruiting

Address

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Site Contact

Site Public Contact

[email protected]

800-782-8581

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

HIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico

Status

Suspended

Address

HIMA San Pablo Oncologic Hospital

Caguas, , 00726

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