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Clinical Trial Finder

Search Results

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Study Purpose

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

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 365 Days - 30 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916) - Patient must be >= 365 days and =< 30 years of age at diagnosis.
  • - Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible: - Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features: - MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR.
  • - Age > 547 days regardless of biologic features.
  • - Patients with INRG stage MS disease with MYCN amplification.
  • - Patients with INRG stage L2 disease with MYCN amplification.
  • - Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M.
  • - Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M.
  • - Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan/cyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible.
  • - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex as follows: - 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.
  • - Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and.
  • - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45.
  • - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram.
  • - No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.

Exclusion Criteria:

  • - Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial) - Patients with bone marrow failure syndromes.
  • - Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders.
  • - Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential.
  • - Lactating females who plan to breastfeed their infants.
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

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.

NCT03126916
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 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven DuBois
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Active, not recruiting
Countries Canada, Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ganglioneuroblastoma, Neuroblastoma
Additional Details

PRIMARY OBJECTIVES:

  • I. To determine in the context of a randomized trial whether the event-free survival (EFS) of patients with newly diagnosed high-risk neuroblastoma (NBL) is improved with the addition of iobenguane I-131 (131I-MIBG) during induction, prior to tandem autologous stem cell transplantation (ASCT).
  • II. To determine whether the addition of lorlatinib to intensive multimodality therapy for patients with high-risk NBL whose tumors harbor activating point mutations in the ALK gene with a variant allele frequency (VAF) >= 5% results in superior EFS compared to a contemporaneously treated cohort of patients with tumors without documented ALK activating mutations.
SECONDARY OBJECTIVES:
  • I. To describe the toxicities associated with treatment for high-risk NBL with and without the addition of 131I-MIBG or ALK inhibitor therapy.
  • II. To estimate EFS and describe toxicity in patients with newly diagnosed high-risk NBL randomized to treatment with an 131I-MIBG-containing induction prior to busulfan/melphalan (BuMel) ASCT.
  • III. To describe the overall survival (OS) and response rates (evaluated per International Neuroblastoma Response Criteria [INRC] criteria prior to ASCT and prior to post-consolidation therapy) for patients with high-risk neuroblastoma treated with or without 131I-MIBG or ALK inhibitor therapy.
  • IV. To prospectively evaluate the relationship of response rate per revised International Neuroblastoma Response Criteria (INRC) to EFS and OS in patients with high-risk NBL treated with and without the addition of 131I-MIBG or ALK inhibitor therapy.
EXPLORATORY OBJECTIVES:
  • I. To evaluate whole body radiation dose, tumor factors, and host factors as potential predictors of efficacy and/or toxicity associated with 131I-MIBG therapy and transplant conditioning.
  • II. To describe end-Induction response, EFS, and OS according to specific ALK mutations, VAF, ALK amplification, the presence of additional genomic findings, or the ALK inhibitor administered.
  • III. To characterize changes in tumor markers (circulating tumor deoxyribonucleic acid [DNA], including ALK and other tumor specific genetic aberrations, and circulating GD2) over time in response to protocol therapy.
  • IV. To correlate results of tumor and host profiling with end-induction response and EFS.
  • V. To prospectively evaluate EFS for patients with MIBG non-avid high-risk NBL compared to patients with MIBG-avid high-risk NBL who are randomized to treatment without 131I-MIBG.
  • VI. To correlate Curie scores calculated from 131I-MIBG post-treatment scans with end-induction response, EFS and OS.
  • VII. To describe changes in image defined risk factors (IDRFs) over the course of induction therapy, with correlation to surgical outcomes and local failure rates following primary tumor resection.
  • VIII. To define patterns of failure at time of first relapse or progression in patients with high-risk NBL.
  • IX. To determine the feasibility of prospectively monitoring adverse events using electronic health records.
  • X. To compare local, central, and computer assisted Curie score assignment at baseline and during therapy in patients with MIBG-avid high-risk NBL.
XI. To compare late toxicities (including impaired organ function and secondary tumor occurrence) in patients treated with 131I-MIBG or ALK inhibitor therapy to late toxicities in patients who have not received these therapies. XII. To determine the association between household material hardship (HMH) and clinical outcomes, including event free and overall survival, and 131I-MIBG receipt. XIII. To compare the outcomes (EFS, OS, and toxicity) of patients treated with post-consolidation therapy that does not contain aldesleukin to historical outcome data for patients treated with similar induction and consolidation regimens followed by post-consolidation therapy that contained aldesleukin. XIV. To characterize and describe longitudinal neuropsychological and behavioral effects of high-risk neuroblastoma therapy. XV. To evaluate change in neurobehavioral outcomes over time in patients with neuroblastoma treated with high-risk neuroblastoma therapy plus lorlatinib compared to high-risk therapy alone using parent- or self-report measures of adaptive, executive, and psychosocial functioning. XVI. To characterize the pharmacokinetics and pharmaceutical properties of lorlatinib in children with high-risk neuroblastoma. OUTLINE: Patients are randomized or assigned to 1 of 5 arms. All patients receive cyclophosphamide intravenously (IV) over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 during cycle 1 of induction therapy in the absence of disease progression or unacceptable toxicity. Patients not assigned to an Arm by the end of cycle 1 may receive an addition cycle of cyclophosphamide and topotecan. ARM A: INDUCTION THERAPY: Patients receive cyclophosphamide IV over 15-30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 of cycle 2 and cisplatin IV over 4 hours and etoposide phosphate IV over 2 hours on days 1-3 of cycles 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on day 1 and dexrazoxane hydrochloride IV over 5-15 minutes, doxorubicin hydrochloride IV over 1-15 minutes, and cyclophosphamide IV over 1-6 hours on days 1-2 of cycle 4 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: HSCT#1: Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 in the absence of disease progression or unacceptable toxicity. HSCT#2: Patients receive melphalan hydrochloride IV over 30 minutes on days -7 to -5, and etoposide phosphate IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4 in the absence of disease progression or unacceptable toxicity. POST-CONSOLIDATION THERAPY: Patients receive sargramostim subcutaneously (SC) on days 1-14, dinutuximab IV over 10 hours on days 4-7 of cycles 1-5, and isotretinoin orally (PO) twice daily (BID) on days 11-24 of cycles 1-5, and days 15-28 during cycle 6 in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or multigated acquisition (MUGA) scan, magnetic resonance imaging (MRI) or computed tomography (CT) scan, receive 123I-MIBG and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study. ARM B: INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, and etoposide phosphate as in Arm A, iobenguane I-131 IV over 1.5-2 hours on day 1 beginning 3 weeks after the start of cycle 3, and vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A beginning no sooner than 35 days after the infusion of iobenguane I-131. CONSOLIDATION THERAPY: HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A. HSCT#2: Patients receive melphalan, etoposide phosphate, and carboplatin as in Arm A. POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A-D. Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study. ARM C (CLOSED TO ACCRUAL AS OF DECEMBER 17, 2020): INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, iobenguane I-131, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm B. CONSOLIDATION THERAPY: Patients receive busulfan IV over 3 hours on days -6 to -3 and melphalan hydrochloride IV over 30 minutes on day -1 in the absence of disease progression or unacceptable toxicity. POST-CONSOLIDATION THERAPY: Patients receive sargramostim, dinutuximab, and isotretinoin as in Arm A. Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study. ARM D: Patients receive treatment identical to Arm A. Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo fludeoxyglucose- positron emission tomography (PET) scan on study. ARM E: INDUCTION THERAPY: Patients receive cyclophosphamide, topotecan hydrochloride, cisplatin, etoposide phosphate, vincristine sulfate, dexrazoxane hydrochloride, doxorubicin hydrochloride, and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO once daily (QD) starting cycle 2 prior to HSCT #1 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: HSCT#1: Patients receive thiotepa and cyclophosphamide as in Arm A. Patients also receive lorlatinib PO QD until day -8 of HSCT#2 in the absence of disease progression or unacceptable toxicity. HSCT#2: Patients receive melphalan hydrochloride, etoposide phosphate, carboplatin as in Arm A. Lorlatinib is restarted when patient has reached at least day +14 post-HSCT#2 and is able to tolerate enteral medications, provided there is no evidence of disease progression or unacceptable toxicity. RADIATION THERAPY: Patients receive lorlatinib PO QD concurrently with radiation therapy in the absence of disease progression or unacceptable toxicity. POST-CONSOLIDATION THERAPY: Patients receive sargramostim and dinutuximab as in Arm A-D. Patients also receive isotretinoin PO BID on days 11-24 of cycles 1-5 and days 15-28 of cycle 6, and lorlatinib PO QD on days 15-28 of cycles 2-5 and days 1-28 of cycle 6 in the absence of disease progression or unacceptable toxicity. CONTINUATION THERAPY: Patients receive lorlatinib PO QD on days 1-28. Cycles repeat every 28 days for 18 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan, MRI or CT scan, receive 123I-MIGB and undergo MIBG imaging, bone marrow aspiration and biopsy and blood sample collection throughout the study and may undergo MRI and PET scan on study. After completion of study therapy, patients in Arms A-D are followed up every 3 months for 18 months, and then every 6 months for 42 months; patients in Arm E are followed up every 3 months for 6 months, and then every 6 months for 42 months.

Arms & Interventions

Arms

Experimental: Arm A (chemotherapy, HSCT, EBRT)

See Arm A in detailed description.

Experimental: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)

See Arm B in detailed description.

Experimental: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)

See Arm C in detailed description. Closed to accrual as of 12/17/20.

Experimental: Arm D (chemotherapy, HSCT, EBRT)

See Arm D in detailed description.

Experimental: Arm E (lorlatinib, chemotherapy, HSCT, EBRT)

See Arm E in detailed description.

Interventions

Procedure: - Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous HSCT

Procedure: - Biospecimen Collection

Undergo blood sample collection

Procedure: - Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Drug: - Busulfan

Given IV

Drug: - Carboplatin

Given IV

Drug: - Cisplatin

Given IV

Procedure: - Computed Tomography

Undergo CT scan

Drug: - Cyclophosphamide

Given IV

Drug: - Dexrazoxane Hydrochloride

Given IV

Biological: - Dinutuximab

Given IV

Drug: - Doxorubicin Hydrochloride

Given IV

Procedure: - Echocardiography

Undergo echocardiography

Drug: - Etoposide Phosphate

Given IV

Radiation: - External Beam Radiation Therapy

Undergo EBRT

Radiation: - Iobenguane I-123

Given 123 I-MIBG

Radiation: - Iobenguane I-131

Given IV

Drug: - Isotretinoin

Given PO

Drug: - Lorlatinib

Given PO

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Drug: - Melphalan Hydrochloride

Given IV

Procedure: - Multigated Acquisition Scan

Undergo MUGA scan

Procedure: - Positron Emission Tomography

Undergo PET scan

Biological: - Sargramostim

Given SC

Procedure: - Therapeutic Conventional Surgery

Undergo standard of care surgery

Drug: - Thiotepa

Given IV

Drug: - Topotecan Hydrochloride

Given IV

Drug: - Vincristine Sulfate

Given IV

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

Address

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Kaiser Permanente Downey Medical Center, Downey, California

Status

Address

Kaiser Permanente Downey Medical Center

Downey, California, 90242

Loma Linda University Medical Center, Loma Linda, California

Status

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Children's Hospital Los Angeles, Los Angeles, California

Status

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Mattel Children's Hospital UCLA, Los Angeles, California

Status

Address

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

Valley Children's Hospital, Madera, California

Status

Address

Valley Children's Hospital

Madera, California, 93636

Kaiser Permanente-Oakland, Oakland, California

Status

Address

Kaiser Permanente-Oakland

Oakland, California, 94611

Children's Hospital of Orange County, Orange, California

Status

Address

Children's Hospital of Orange County

Orange, California, 92868

Palo Alto, California

Status

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

Sacramento, California

Status

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

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

Status

Address

Rady Children's Hospital - San Diego

San Diego, California, 92123

Naval Medical Center -San Diego, San Diego, California

Status

Address

Naval Medical Center -San Diego

San Diego, California, 92134

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Children's Hospital Colorado, Aurora, Colorado

Status

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Denver, Colorado

Status

Address

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

Denver, Colorado, 80218

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Yale University, New Haven, Connecticut

Status

Address

Yale University

New Haven, Connecticut, 06520

Alfred I duPont Hospital for Children, Wilmington, Delaware

Status

Address

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

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

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Fort Myers, Florida

Status

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Gainesville, Florida

Status

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Hollywood, Florida

Status

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Miami, Florida

Status

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Nicklaus Children's Hospital, Miami, Florida

Status

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

AdventHealth Orlando, Orlando, Florida

Status

Address

AdventHealth Orlando

Orlando, Florida, 32803

Nemours Children's Hospital, Orlando, Florida

Status

Address

Nemours Children's Hospital

Orlando, Florida, 32827

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

Status

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Saint Mary's Medical Center, West Palm Beach, Florida

Status

Address

Saint Mary's Medical Center

West Palm Beach, Florida, 33407

Atlanta, Georgia

Status

Address

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

Savannah, Georgia

Status

Address

Memorial Health University Medical Center

Savannah, Georgia, 31404

Honolulu, Hawaii

Status

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

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

Status

Address

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Lurie Children's Hospital-Chicago, Chicago, Illinois

Status

Address

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

University of Illinois, Chicago, Illinois

Status

Address

University of Illinois

Chicago, Illinois, 60612

Chicago, Illinois

Status

Address

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois

Status

Address

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois

Status

Address

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

Saint Jude Midwest Affiliate, Peoria, Illinois

Status

Address

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Springfield, Illinois

Status

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Riley Hospital for Children, Indianapolis, Indiana

Status

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Blank Children's Hospital, Des Moines, Iowa

Status

Address

Blank Children's Hospital

Des Moines, Iowa, 50309

Iowa City, Iowa

Status

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Lexington, Kentucky

Status

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Children's Hospital New Orleans, New Orleans, Louisiana

Status

Address

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Ochsner Medical Center Jefferson, New Orleans, Louisiana

Status

Address

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Eastern Maine Medical Center, Bangor, Maine

Status

Address

Eastern Maine Medical Center

Bangor, Maine, 04401

Maine Children's Cancer Program, Scarborough, Maine

Status

Address

Maine Children's Cancer Program

Scarborough, Maine, 04074

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Baltimore, Maryland

Status

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Bethesda, Maryland

Status

Address

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

Tufts Children's Hospital, Boston, Massachusetts

Status

Address

Tufts Children's Hospital

Boston, Massachusetts, 02111

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

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

Status

Address

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Children's Hospital of Michigan, Detroit, Michigan

Status

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201

Detroit, Michigan

Status

Address

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

Henry Ford Health Saint John Hospital, Detroit, Michigan

Status

Address

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

Michigan State University, East Lansing, Michigan

Status

Address

Michigan State University

East Lansing, Michigan, 48823

Grand Rapids, Michigan

Status

Address

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

Grand Rapids, Michigan, 49503

Bronson Methodist Hospital, Kalamazoo, Michigan

Status

Address

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Corewell Health Children's, Royal Oak, Michigan

Status

Address

Corewell Health Children's

Royal Oak, Michigan, 48073

Minneapolis, Minnesota

Status

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Minneapolis, Minnesota

Status

Address

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

University of Mississippi Medical Center, Jackson, Mississippi

Status

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Columbia, Missouri

Status

Address

University of Missouri Children's Hospital

Columbia, Missouri, 65212

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

Status

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Washington University School of Medicine, Saint Louis, Missouri

Status

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Mercy Hospital Saint Louis, Saint Louis, Missouri

Status

Address

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

Omaha, Nebraska

Status

Address

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

University of Nebraska Medical Center, Omaha, Nebraska

Status

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Las Vegas, Nevada

Status

Address

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Sunrise Hospital and Medical Center, Las Vegas, Nevada

Status

Address

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

Las Vegas, Nevada

Status

Address

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Summerlin Hospital Medical Center, Las Vegas, Nevada

Status

Address

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

Lebanon, New Hampshire

Status

Address

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

Hackensack University Medical Center, Hackensack, New Jersey

Status

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Morristown Medical Center, Morristown, New Jersey

Status

Address

Morristown Medical Center

Morristown, New Jersey, 07960

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

Status

Address

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

New Brunswick, New Jersey

Status

Address

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

New Brunswick, New Jersey, 08903

Newark Beth Israel Medical Center, Newark, New Jersey

Status

Address

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

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

Status

Address

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

University of New Mexico Cancer Center, Albuquerque, New Mexico

Status

Address

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

Albany Medical Center, Albany, New York

Status

Address

Albany Medical Center

Albany, New York, 12208

Montefiore Medical Center - Moses Campus, Bronx, New York

Status

Address

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

Maimonides Medical Center, Brooklyn, New York

Status

Address

Maimonides Medical Center

Brooklyn, New York, 11219

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

NYU Langone Hospital - Long Island, Mineola, New York

Status

Address

NYU Langone Hospital - Long Island

Mineola, New York, 11501

New Hyde Park, New York

Status

Address

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

New Hyde Park, New York, 11040

New York, New York

Status

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

New York, New York

Status

Address

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

New York, New York, 10032

University of Rochester, Rochester, New York

Status

Address

University of Rochester

Rochester, New York, 14642

Stony Brook University Medical Center, Stony Brook, New York

Status

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Syracuse, New York

Status

Address

State University of New York Upstate Medical University

Syracuse, New York, 13210

New York Medical College, Valhalla, New York

Status

Address

New York Medical College

Valhalla, New York, 10595

Mission Hospital, Asheville, North Carolina

Status

Address

Mission Hospital

Asheville, North Carolina, 28801

Chapel Hill, North Carolina

Status

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Charlotte, North Carolina

Status

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

East Carolina University, Greenville, North Carolina

Status

Address

East Carolina University

Greenville, North Carolina, 27834

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

Status

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Sanford Broadway Medical Center, Fargo, North Dakota

Status

Address

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Rainbow Babies and Childrens Hospital, Cleveland, Ohio

Status

Address

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Nationwide Children's Hospital, Columbus, Ohio

Status

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Dayton Children's Hospital, Dayton, Ohio

Status

Address

Dayton Children's Hospital

Dayton, Ohio, 45404

Toledo, Ohio

Status

Address

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

Oklahoma City, Oklahoma

Status

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Legacy Emanuel Children's Hospital, Portland, Oregon

Status

Address

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania

Status

Address

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

Geisinger Medical Center, Danville, Pennsylvania

Status

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Rhode Island Hospital, Providence, Rhode Island

Status

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Prisma Health Richland Hospital, Columbia, South Carolina

Status

Address

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

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

Status

Address

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

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

Status

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Saint Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

Nashville, Tennessee

Status

Address

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

Nashville, Tennessee

Status

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Austin, Texas

Status

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Driscoll Children's Hospital, Corpus Christi, Texas

Status

Address

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

Medical City Dallas Hospital, Dallas, Texas

Status

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Dallas, Texas

Status

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

El Paso Children's Hospital, El Paso, Texas

Status

Address

El Paso Children's Hospital

El Paso, Texas, 79905

Cook Children's Medical Center, Fort Worth, Texas

Status

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Houston, Texas

Status

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Covenant Children's Hospital, Lubbock, Texas

Status

Address

Covenant Children's Hospital

Lubbock, Texas, 79410

UMC Cancer Center / UMC Health System, Lubbock, Texas

Status

Address

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415

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

Status

Address

Children's Hospital of San Antonio

San Antonio, Texas, 78207

San Antonio, Texas

Status

Address

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Primary Children's Hospital, Salt Lake City, Utah

Status

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Burlington, Vermont

Status

Address

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

Richmond, Virginia

Status

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Seattle Children's Hospital, Seattle, Washington

Status

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Spokane, Washington

Status

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Tacoma, Washington

Status

Address

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

Madigan Army Medical Center, Tacoma, Washington

Status

Address

Madigan Army Medical Center

Tacoma, Washington, 98431

West Virginia University Healthcare, Morgantown, West Virginia

Status

Address

West Virginia University Healthcare

Morgantown, West Virginia, 26506

Green Bay, Wisconsin

Status

Address

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

Madison, Wisconsin

Status

Address

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin

Status

Address

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Children's Hospital of Wisconsin, Milwaukee, Wisconsin

Status

Address

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

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

Status

Address

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

Status

Address

Janeway Child Health Centre

Saint John's, Newfoundland and Labrador, A1B 3V6

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

Hamilton, Ontario, Canada

Status

Address

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Status

Address

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7

Children's Hospital, London, Ontario, Canada

Status

Address

Children's Hospital

London, Ontario, N6A 5W9

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Status

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

HIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico

Status

Address

HIMA San Pablo Oncologic Hospital

Caguas, , 00726

Resources

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  • Clinical Trial Endpoints
  • Research Resources
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