Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Study Purpose

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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:

- Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F based on the presence of an actionable mutation.

- Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment.

- Patients must have a body surface area >= 0.5 m^2 at enrollment.

- Patients must have radiographically measurable disease at the time of study enrollment.

Patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on a standard MRI or CT.

- Note: The following do not qualify as measurable disease: - Malignant fluid collections (e.g., ascites, pleural effusions) - Bone marrow infiltration except that detected by MIBG scan for neuroblastoma.

- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma.

- Elevated tumor markers in plasma or cerebrospinal fluid (CSF) - Previously radiated lesions that have not demonstrated clear progression post radiation.

- Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age.

- Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; 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.

- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately.

- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea) - Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent.

- Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1.

- Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid.

- Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator.

- Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors) - Stem cell Infusions (with or without total body irradiation [TBI]): - Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD) - Autologous stem cell infusion including boost infusion: >= 42 days.

- Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.) - Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation.

- Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment.

- Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy.

- Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater.

- For patients with solid tumors without known bone marrow involvement: - Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment) - Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment) - Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity.

- 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 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female.

- Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female.

- Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female.

- Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female.

- Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female.

- Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female.

- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) - Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) (for the purpose of this study, the ULN for SGPT is 45 U/L) - Serum albumin >= 2 g/dL (within 7 days prior to enrollment) - Patients must be able to swallow intact capsules.

- All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria:

- Pregnant or breast-feeding women will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib.

- Concomitant medications.

- Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid.

- Investigational drugs: patients who are currently receiving another investigational drug are not eligible.

- Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible.

- Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial.

- CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study.

- Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed.

- Patients who have an uncontrolled infection are not eligible.

- Patients who have received a prior solid organ transplantation are not eligible.

- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

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.	NCT03213652
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.	Meredith S Irwin
Principal Investigator Affiliation	Children's Oncology Group
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH, Other
Overall Status	Recruiting
Countries	Australia, Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Ependymoma, Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Wilms Tumor

Additional Details

PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

II. To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to ensartinib and specifically, whether tumors that harbor different missense mutations or fusions (including the crizotinib resistant F1174L ALK variant) will demonstrate differential response to ensartinib treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE: Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Arms & Interventions

Arms

Experimental: Treatment (ensartinib)

Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Interventions

Procedure: - Biospecimen Collection

Undergo blood sample collection

Procedure: - Bone Marrow Aspiration and Biopsy

Undergo a bone marrow aspiration and/or biopsy

Procedure: - Bone Scan

Undergo a bone scan

Procedure: - Computed Tomography

Undergo a CT scan

Drug: - Ensartinib

Given PO

Other: - Laboratory Biomarker Analysis

Correlative studies

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Other: - Pharmacological Study

Correlative studies

Procedure: - Positron Emission Tomography

Undergo a PET scan

Procedure: - Radionuclide Imaging

Undergo radionuclide imaging

Procedure: - X-Ray Imaging

Undergo an x-ray

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

Providence Alaska Medical Center, Anchorage, Alaska

Status

Recruiting

Address

Providence Alaska Medical Center

Anchorage, Alaska, 99508

Site Contact

Site Public Contact

[email protected]

907-212-6871

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

Tucson, Arizona

Status

Recruiting

Address

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

Site Contact

Site Public Contact

[email protected]

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

Valley Children's Hospital, Madera, California

Status

Recruiting

Address

Valley Children's Hospital

Madera, California, 93636

Site Contact

Site Public Contact

[email protected]

559-353-3000

UCSF Benioff Children's Hospital Oakland, Oakland, California

Status

Recruiting

Address

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

Site Contact

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

Site Contact

Site Public Contact

[email protected]

714-509-8646

Sacramento, California

Status

Recruiting

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Site Contact

Site Public Contact

916-734-3089

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

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

Denver, Colorado

Status

Recruiting

Address

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218

Site Contact

Site Public Contact

303-839-6000

Yale University, New Haven, Connecticut

Status

Suspended

Address

Yale University

New Haven, Connecticut, 06520

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

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

Gainesville, Florida

Status

Recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Site Contact

Site Public Contact

[email protected]

352-273-8010

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

Nemours Children's Clinic - Pensacola, Pensacola, Florida

Status

Active, not recruiting

Address

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504

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, Florida

Status

Active, not recruiting

Address

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

Tampa, Florida, 33607

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

Site Contact

Site Public Contact

[email protected]

404-785-2025

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

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

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Site Contact

Site Public Contact

217-545-7929

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

Site Contact

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

Site Contact

Site Public Contact

800-237-1225

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

Suspended

Address

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Recruiting

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Site Contact

Site Public Contact

[email protected]

410-601-6120

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

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

East Lansing, Michigan

Status

Recruiting

Address

Michigan State University Clinical Center

East Lansing, Michigan, 48824

Site Contact

Site Public Contact

517-975-9547

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

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

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Withdrawn

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

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

Las Vegas, Nevada

Status

Suspended

Address

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Las Vegas, Nevada

Status

Suspended

Address

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Summerlin Hospital Medical Center, Las Vegas, Nevada

Status

Suspended

Address

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

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

Saint Peter's University Hospital, New Brunswick, New Jersey

Status

Recruiting

Address

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

Site Contact

Site Public Contact

[email protected]

732-745-8600 #6163

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

NYP/Weill Cornell Medical Center, New York, New York

Status

Recruiting

Address

NYP/Weill Cornell Medical Center

New York, New York, 10065

Site Contact

Site Public Contact

212-746-1848

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Site Public Contact

585-275-5830

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

New York Medical College, Valhalla, New York

Status

Recruiting

Address

New York Medical College

Valhalla, New York, 10595

Site Contact

Site Public Contact

914-594-3794

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

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Site Public Contact

888-275-3853

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina

Status

Not yet recruiting

Address

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

Site Contact

David E. Kram

[email protected]

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

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

Suspended

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

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

Geisinger Medical Center, Danville, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

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

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

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Suspended

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

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

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

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-575-6240

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

Burlington, Vermont

Status

Recruiting

Address

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

Site Contact

Site Public Contact

[email protected]

802-656-8990

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

Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Site Public Contact

[email protected]

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

Madigan Army Medical Center, Tacoma, Washington

Status

Recruiting

Address

Madigan Army Medical Center

Tacoma, Washington, 98431

Site Contact

Site Public Contact

[email protected]

253-968-6144

West Virginia University Healthcare, Morgantown, West Virginia

Status

Active, not recruiting

Address

West Virginia University Healthcare

Morgantown, West Virginia, 26506

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

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]

San Jorge Children's Hospital, San Juan, Puerto Rico

Status

Active, not recruiting

Address

San Jorge Children's Hospital

San Juan, , 00912

University Pediatric Hospital, San Juan, Puerto Rico

Status

Recruiting

Address

University Pediatric Hospital

San Juan, , 00926

Site Contact

Site Public Contact

787-474-0333

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