A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

NCT ID: NCT04684368

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2029-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To monitor outcome to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with induction chemotherapy followed by response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122 (NCT00047320).

II. To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123 (NCT01602666).

SECONDARY OBJECTIVES:

I. To estimate the response rates to induction chemotherapy and WVSCI for localized NGGCT patients who achieve a CR/PR.

II. To estimate the PFS and overall survival (OS) for localized NGGCT patients who achieve a CR/PR and receive WVSCI.

III. To estimate the PFS and OS for patients with less than a CR/PR following Induction who subsequently receive high-dose chemotherapy with peripheral stem cell rescue (HDCSCR).

IV. To estimate the response rate for patients with less than a CR/PR following Induction who subsequently receive HDCSCR.

EXPLORATORY OBJECTIVES:

I. To prospectively compare outcomes based on radiation modality, photon versus proton, including cognitive, social and behavioral functioning, auditory, and neuro-endocrine function.

II. To compare spinal column growth and cell counts following radiation as measured by height and weight, and complete blood count (CBC) values during and after radiation therapy, based on treatment modality (photon versus \[vs.\] proton therapy) and planned inclusion/exclusion of the vertebral body in patients \< 13 years of age.

III. To compare local vs. central review recommendations for second-look surgery and document barriers for performing such surgeries as well as their clinical benefit in pediatric NGGCT.

IV. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral functioning of children and young adults with localized CNS NGGCT with testing as per the Children's Oncology Group (COG) Standardized Neuropsychological and Behavioral Battery.

V. To evaluate patterns of disease recurrence/failure with respect to radiation dose distribution.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of cycles 1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide IV over 60-120 minutes on days 1-5 of cycles 2, 4, and 6. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients are assigned to 1 of 2 plans (ventricular + spinal canal irradiation \[WVSCI\] or high-dose chemotherapy with peripheral stem cell rescue \[HDCSCR\]) based on response to induction chemotherapy:

* Patients who achieve radiographic CR/PR with marker normalization proceed to WVSCI. Patients who achieve radiographic CR without marker normalization proceed to HDCSCR.
* Patients who achieve less than radiographic CR/PR with marker normalization proceed to second-look surgery (unless contraindicated). If second-look surgery reveals mature teratoma or non-viable tumor, proceed to WVSCI. If second-look surgery reveals viable tumor, proceed to HDCSCR. Patients who are unable to undergo second-look surgery are removed from protocol therapy but remain on study for follow-up.
* Patients who achieve less than radiographic CR/PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.
* Patients who achieve radiographic PR without marker normalization proceed to second-look surgery (unless contraindicated). Patients then proceed to HDCSCR regardless of whether or not a second-look surgery is performed.

PLAN A (WVSCI THERAPY): Within 6 weeks of the end of induction chemotherapy or second-look surgery, patients undergo WVSCI once daily (QD) for 5 days weekly (17 fractions followed by a boost dose for 13 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.

PLAN B (CONSOLIDATION THERAPY \[HDCSCR\]): Within 6-8 weeks of the end of induction chemotherapy or second-look surgery, patients receive etoposide IV and thiotepa IV over 3 hours on days -5 to -3 and undergo peripheral blood stem cell (PBSC) transplant on day 0. Patients then undergo radiation therapy QD for 5 days weekly (20 fractions followed by a boost dose for 10 fractions) for 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients also undergo magnetic resonance imaging (MRI), as well as collection of cerebral spinal fluid (CSF) and blood sample throughout the trial.

After completion of study treatment, patients are followed for up to 10 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System Nongerminomatous Germ Cell Tumor Choriocarcinoma Embryonal Carcinoma Immature Teratoma Malignant Teratoma Mixed Germ Cell Tumor Pineal Region Germ Cell Tumor Pineal Region Immature Teratoma Pineal Region Yolk Sac Tumor Suprasellar Germ Cell Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Plan A (chemotherapy, WVSCI, second-look surgery if needed)

See Outline in Detailed Description.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of CSF and blood samples

Carboplatin

Intervention Type DRUG

Given IV

Etoposide

Intervention Type DRUG

Given IV

Filgrastim

Intervention Type BIOLOGICAL

Given subcutaneously (SC) or IV

Ifosfamide

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Mesna

Intervention Type DRUG

Given IV or orally

Pegfilgrastim

Intervention Type BIOLOGICAL

Given SC

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo WVSCI radiation therapy

Second-Look Surgery

Intervention Type PROCEDURE

Undergo second-look surgery if needed

Plan B (chemotherapy, HDCSCR, second-look surgery if needed)

See Outline in Detailed Description.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of CSF and blood samples

Carboplatin

Intervention Type DRUG

Given IV

Etoposide

Intervention Type DRUG

Given IV

Filgrastim

Intervention Type BIOLOGICAL

Given subcutaneously (SC) or IV

Ifosfamide

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Mesna

Intervention Type DRUG

Given IV or orally

Pegfilgrastim

Intervention Type BIOLOGICAL

Given SC

Peripheral Blood Stem Cell Transplantation

Intervention Type PROCEDURE

Undergo PBSC transplant

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Radiation Therapy

Intervention Type RADIATION

Undergo radiation therapy

Second-Look Surgery

Intervention Type PROCEDURE

Undergo second-look surgery if needed

Thiotepa

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo collection of CSF and blood samples

Intervention Type PROCEDURE

Carboplatin

Given IV

Intervention Type DRUG

Etoposide

Given IV

Intervention Type DRUG

Filgrastim

Given subcutaneously (SC) or IV

Intervention Type BIOLOGICAL

Ifosfamide

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Mesna

Given IV or orally

Intervention Type DRUG

Pegfilgrastim

Given SC

Intervention Type BIOLOGICAL

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplant

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Radiation Therapy

Undergo WVSCI radiation therapy

Intervention Type RADIATION

Radiation Therapy

Undergo radiation therapy

Intervention Type RADIATION

Second-Look Surgery

Undergo second-look surgery if needed

Intervention Type PROCEDURE

Thiotepa

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 JM8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid VP 16 VP 16-213 VP 16213 VP-16 VP-16-213 VP-16213 VP16 VP16213 Filgrastim Biosimilar Filgrastim-sndz Filgrastim Biosimilar Tbo-filgrastim Filgrastim XM02 Filgrastim-aafi Filgrastim-ayow Filgrastim-sndz G-CSF Granix Neupogen Neutroval Nivestim Nivestym r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor Releuko rG-CSF Tbo-filgrastim Tevagrastim XM02 Zarxio Asta Z 4942 Asta Z-4942 Cyfos Holoxan Holoxane Ifex IFO IFO-Cell Ifolem Ifomida Ifomide Ifosfamidum Ifoxan IFX Iphosphamid Iphosphamide Iso-Endoxan Isoendoxan Isophosphamide Mitoxana MJF 9325 MJF-9325 Naxamide Seromida Tronoxal Z 4942 Z-4942 Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI 2-Mercaptoethanesulfonate, Sodium Salt Ausobronc D-7093 Filesna Mercaptoethane Sulfonate Mercaptoethanesulfonate Mesnex Mesnil Mesnum Mexan Mistabron Mistabronco Mitexan Mucofluid Mucolene UCB 3983 Uromitexan Ziken Dulastin Filgrastim SD-01 filgrastim-SD/01 Fulphila Fylnetra G-Lasta HSP-130 Jinyouli Neulasta Neulastim Neupopeg Nyvepria PEG-filgrastim Pegcyte Pegfilgrastim Biosimilar HSP-130 Pegfilgrastim Biosimilar Nyvepria Pegfilgrastim Biosimilar Pegcyte Pegfilgrastim Biosimilar PF-06881894 Pegfilgrastim Biosimilar Udenyca Pegfilgrastim Biosimilar Ziextenzo Pegfilgrastim-apgf Pegfilgrastim-bmez Pegfilgrastim-cbqv Pegfilgrastim-fpgk Pegfilgrastim-jmdb Pegfilgrastim-pbbk Pegylated G-CSF Pegylated GCSF Pegylated Granulocyte Colony Stimulating Factor PF-06881894 SD-01 SD-01 sustained duration G-CSF Stimufend Tripegfilgrastim Udenyca Ziextenzo PBPC transplantation PBSCT Peripheral Blood Peripheral Blood Progenitor Cell Transplantation PERIPHERAL BLOOD STEM CELL TRANSPLANT Peripheral Stem Cell Support Peripheral Stem Cell Transplant Peripheral Stem Cell Transplantation Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Cancer Radiotherapy Energy Type ENERGY_TYPE Irradiate Irradiated Irradiation Radiation Radiation Therapy, NOS Radiotherapeutics Radiotherapy RT Therapy, Radiation Reoperation Repeat Surgery Second Look Surgical Revision 1,1',1''-Phosphinothioylidynetrisaziridine Girostan N,N', N''-Triethylenethiophosphoramide Oncotiotepa SH 105 SH-105 SH105 STEPA Tepadina Tepylute TESPA Tespamin Tespamine Thio-Tepa Thiofosfamide Thiofozil Thiophosphamide Thiophosphoamide Thiophosphoramide Thiotef Tifosyl TIO TEF Tio-tef Triethylene Thiophosphoramide Triethylenethiophosphoramide Tris(1-aziridinyl)phosphine sulfide TSPA WR 45312

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must be \>= 3 years and \< 30 years at the time of study enrollment
* Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \> 10 ng/mL or human chorionic gonadotropin (hCG) beta \> 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded
* Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
* Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )
* Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)
* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery
* Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
* 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 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):

* Age: Maximum serum creatinine (mg/dL)

* 3 to \< 6 years: 0.8 (male), 0.8 (female)
* 6 to \< 10 years: 1 (male), 1 (female)
* 10 to \< 13 years: 1.2 (male), 1.2 (female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: male (1.7), 1.4 (female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment)

* Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
* Central nervous system function defined as:

* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
* Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
* Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. 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.
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
* NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:
* English-, Spanish-, or French- speaking

* Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments
* No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate
* Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery

* Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires

Exclusion Criteria

* Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)
* Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
* Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
* Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)
* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs

* Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shannon M MacDonald

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status SUSPENDED

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status RECRUITING

Banner Children's at Desert

Mesa, Arizona, United States

Site Status RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Site Status RECRUITING

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status SUSPENDED

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status SUSPENDED

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Valley Children's Hospital

Madera, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

Children's Hospital of Orange County

Orange, California, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, United States

Site Status RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Site Status RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Site Status RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Hospital

Orlando, Florida, United States

Site Status RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Site Status RECRUITING

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status SUSPENDED

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Site Status RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status RECRUITING

Blank Children's Hospital

Des Moines, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Site Status RECRUITING

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status RECRUITING

Maine Children's Cancer Program

Scarborough, Maine, United States

Site Status RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status RECRUITING

Michigan State University

East Lansing, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status SUSPENDED

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

Grand Rapids, Michigan, United States

Site Status RECRUITING

Corewell Health Children's

Royal Oak, Michigan, United States

Site Status RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

University of Missouri Children's Hospital

Columbia, Missouri, United States

Site Status RECRUITING

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status RECRUITING

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

Site Status SUSPENDED

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Site Status SUSPENDED

Renown Regional Medical Center

Reno, Nevada, United States

Site Status RECRUITING

Cancer Care Specialists - Reno

Reno, Nevada, United States

Site Status SUSPENDED

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status RECRUITING

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

New Brunswick, New Jersey, United States

Site Status RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status SUSPENDED

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Site Status RECRUITING

Albany Medical Center

Albany, New York, United States

Site Status RECRUITING

Maimonides Medical Center

Brooklyn, New York, United States

Site Status RECRUITING

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

New Hyde Park, New York, United States

Site Status RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status SUSPENDED

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

New York Medical College

Valhalla, New York, United States

Site Status RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Dayton Children's Hospital

Dayton, Ohio, United States

Site Status RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status SUSPENDED

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Site Status RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Site Status RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status SUSPENDED

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Site Status RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status RECRUITING

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

El Paso Children's Hospital

El Paso, Texas, United States

Site Status RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Site Status RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Carilion Children's

Roanoke, Virginia, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Site Status RECRUITING

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Site Status RECRUITING

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status RECRUITING

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status SUSPENDED

Sydney Children's Hospital

Randwick, New South Wales, Australia

Site Status RECRUITING

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Site Status RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Site Status RECRUITING

Royal Children's Hospital

Parkville, Victoria, Australia

Site Status RECRUITING

Perth Children's Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

Site Status RECRUITING

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

Québec, , Canada

Site Status RECRUITING

Christchurch Hospital

Christchurch, , New Zealand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada New Zealand

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Site Public Contact

Role: primary

907-212-6871

Site Public Contact

Role: primary

480-412-3100

Site Public Contact

Role: primary

602-546-0920

Site Public Contact

Role: primary

Site Public Contact

Role: primary

501-364-7373

Site Public Contact

Role: primary

626-564-3455

Site Public Contact

Role: primary

909-558-4050

Site Public Contact

Role: primary

562-933-5600

Site Public Contact

Role: primary

323-361-4110

Site Public Contact

Role: primary

310-423-8965

Site Public Contact

Role: primary

559-353-3000

Site Public Contact

Role: primary

877-642-4691

Site Public Contact

Role: primary

714-509-8646

Site Public Contact

Role: primary

800-694-0012

Site Public Contact

Role: primary

858-966-5934

Site Public Contact

Role: primary

877-827-3222

Site Public Contact

Role: primary

303-764-5056

Site Public Contact

Role: primary

860-545-9981

Site Public Contact

Role: primary

203-785-5702

Site Public Contact

Role: primary

302-651-5572

Site Public Contact

Role: primary

202-476-2800

Site Public Contact

Role: primary

239-343-5333

Site Public Contact

Role: primary

352-273-8010

Site Public Contact

Role: primary

302-651-5572

Site Public Contact

Role: primary

305-243-2647

Site Public Contact

Role: primary

888-624-2778

Site Public Contact

Role: primary

321-841-5357

Site Public Contact

Role: primary

302-651-5572

Site Public Contact

Role: primary

Site Public Contact

Role: primary

727-767-4784

Site Public Contact

Role: primary

813-357-0849

Site Public Contact

Role: primary

404-785-0232

Site Public Contact

Role: primary

808-983-6090

Site Public Contact

Role: primary

208-381-2774

Site Public Contact

Role: primary

773-880-4562

Site Public Contact

Role: primary

312-355-3046

Site Public Contact

Role: primary

773-702-8222

Site Public Contact

Role: primary

708-226-4357

Site Public Contact

Role: primary

888-226-4343

Sandeep Batra

Role: primary

317-944-8784

Site Public Contact

Role: primary

515-241-8912

Site Public Contact

Role: primary

800-237-1225

Site Public Contact

Role: primary

859-257-3379

Site Public Contact

Role: primary

502-629-5500

Site Public Contact

Role: primary

504-842-8084

Site Public Contact

Role: primary

207-973-4274

Site Public Contact

Role: primary

207-396-8670

Site Public Contact

Role: primary

410-601-9083

Site Public Contact

Role: primary

410-955-8804

Site Public Contact

Role: primary

877-726-5130

Site Public Contact

Role: primary

877-442-3324

Site Public Contact

Role: primary

800-865-1125

Site Public Contact

Role: primary

Site Public Contact

Role: primary

616-391-1230

Site Public Contact

Role: primary

248-551-7695

Site Public Contact

Role: primary

612-813-5913

Site Public Contact

Role: primary

855-776-0015

Site Public Contact

Role: primary

601-815-6700

Site Public Contact

Role: primary

573-882-1960

Site Public Contact

Role: primary

816-302-6808

Site Public Contact

Role: primary

314-268-4000

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

314-251-7066

Site Public Contact

Role: primary

402-955-3949

Site Public Contact

Role: primary

402-559-6941

Site Public Contact

Role: primary

702-384-0013

Site Public Contact

Role: primary

800-639-6918

Site Public Contact

Role: primary

551-996-2897

Site Public Contact

Role: primary

973-971-5900

Site Public Contact

Role: primary

732-745-8600 ext. 6163

Site Public Contact

Role: primary

732-235-8675

Site Public Contact

Role: primary

973-754-2207

Site Public Contact

Role: primary

518-262-5513

Site Public Contact

Role: primary

718-765-2500

Site Public Contact

Role: primary

718-470-3460

Site Public Contact

Role: primary

Site Public Contact

Role: primary

212-639-7592

Site Public Contact

Role: primary

585-275-5830

Site Public Contact

Role: primary

800-862-2215

Site Public Contact

Role: primary

315-464-5476

Site Public Contact

Role: primary

718-379-6866

Site Public Contact

Role: primary

914-594-3794

Site Public Contact

Role: primary

800-804-9376

Site Public Contact

Role: primary

888-275-3853

Site Public Contact

Role: primary

252-744-1015

Site Public Contact

Role: primary

336-713-6771

Site Public Contact

Role: primary

701-323-5760

Site Public Contact

Role: primary

330-543-3193

Site Public Contact

Role: primary

513-636-2799

Site Public Contact

Role: primary

216-844-5437

Site Public Contact

Role: primary

614-722-6039

Site Public Contact

Role: primary

800-228-4055

Site Public Contact

Role: primary

419-824-1842

Site Public Contact

Role: primary

405-271-8777

Site Public Contact

Role: primary

503-413-2560

Site Public Contact

Role: primary

503-494-1080

Site Public Contact

Role: primary

610-402-9543

Site Public Contact

Role: primary

570-271-5251

Site Public Contact

Role: primary

717-531-6012

Site Public Contact

Role: primary

215-427-8991

Site Public Contact

Role: primary

412-692-8570

Site Public Contact

Role: primary

401-444-1488

Site Public Contact

Role: primary

843-792-9321

Site Public Contact

Role: primary

864-522-4317

Site Public Contact

Role: primary

864-522-4317

Site Public Contact

Role: primary

605-312-3320

Site Public Contact

Role: primary

888-226-4343

Site Public Contact

Role: primary

615-342-1919

Site Public Contact

Role: primary

800-811-8480

Site Public Contact

Role: primary

512-628-1902

Site Public Contact

Role: primary

361-694-5311

Site Public Contact

Role: primary

972-566-5588

Daniel C. Bowers

Role: primary

214-648-3896

Site Public Contact

Role: primary

915-298-5444

Site Public Contact

Role: primary

682-885-2103

Site Public Contact

Role: primary

713-798-1354

Najat C. Daw

Role: primary

713-792-6315

Site Public Contact

Role: primary

210-704-2894

Site Public Contact

Role: primary

210-575-6240

Site Public Contact

Role: primary

210-450-3800

Site Public Contact

Role: primary

801-585-5270

Site Public Contact

Role: primary

802-656-8990

Site Public Contact

Role: primary

434-243-6303

Site Public Contact

Role: primary

757-668-7243

Site Public Contact

Role: primary

804-628-6430

Site Public Contact

Role: primary

540-266-6238

Site Public Contact

Role: primary

866-987-2000

Site Public Contact

Role: primary

800-228-6618

Site Public Contact

Role: primary

253-403-1461

Site Public Contact

Role: primary

253-968-6144

Site Public Contact

Role: primary

304-293-7374

Site Public Contact

Role: primary

800-622-8922

Site Public Contact

Role: primary

(02) 9382-1721

Site Public Contact

Role: primary

61-2-9845 1400

Site Public Contact

Role: primary

61 7 3068 1111

Site Public Contact

Role: primary

61 3 9345 5656

Site Public Contact

Role: primary

Site Public Contact

Role: primary

403-220-6898

Site Public Contact

Role: primary

780-407-8798

Site Public Contact

Role: primary

604-875-2345 ext. 6477

Site Public Contact

Role: primary

866-561-1026

Site Public Contact

Role: primary

902-470-8520

Site Public Contact

Role: primary

905-521-2100

Site Public Contact

Role: primary

416-813-7654

Site Public Contact

Role: primary

514-412-4445

Site Public Contact

Role: primary

514-345-4931

Site Public Contact

Role: primary

819-820-6480

Site Public Contact

Role: primary

418-525-4444

Site Public Contact

Role: primary

03 364 0640

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-13175

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACNS2021

Identifier Type: OTHER

Identifier Source: secondary_id

ACNS2021

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180886

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACNS2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.