Trial Title:
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
NCT ID:
NCT05691478
Condition:
High Grade Osteosarcoma
Localized Osteosarcoma
Metastatic Osteosarcoma
Secondary Osteosarcoma
Conditions: Official terms:
Osteosarcoma
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Single-arm Feasibility Phase study followed by a randomized, parallel 4-arm Efficacy
Phase study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scintography
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Bone Scintigraphy
Intervention type:
Drug
Intervention name:
Cabozantinib S-malate
Description:
Given PO
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
BMS-907351
Other name:
Cabometyx
Other name:
Cometriq
Other name:
XL 184
Other name:
XL-184
Other name:
XL184
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Given IV
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Abiplatin
Other name:
Blastolem
Other name:
Briplatin
Other name:
CDDP
Other name:
Cis-diammine-dichloroplatinum
Other name:
Cis-diamminedichloridoplatinum
Other name:
Cis-diamminedichloro Platinum (II)
Other name:
Cis-diamminedichloroplatinum
Other name:
Cis-dichloroammine Platinum (II)
Other name:
Cis-platinous Diamine Dichloride
Other name:
Cis-platinum
Other name:
Cis-platinum II
Other name:
Cis-platinum II Diamine Dichloride
Other name:
Cismaplat
Other name:
Cisplatina
Other name:
Cisplatinum
Other name:
Cisplatyl
Other name:
Citoplatino
Other name:
Citosin
Other name:
Cysplatyna
Other name:
DDP
Other name:
Lederplatin
Other name:
Metaplatin
Other name:
Neoplatin
Other name:
Peyrone's Chloride
Other name:
Peyrone's Salt
Other name:
Placis
Other name:
Plastistil
Other name:
Platamine
Other name:
Platiblastin
Other name:
Platiblastin-S
Other name:
Platinex
Other name:
Platinol
Other name:
Platinol- AQ
Other name:
Platinol-AQ
Other name:
Platinol-AQ VHA Plus
Other name:
Platinoxan
Other name:
Platinum
Other name:
Platinum Diamminodichloride
Other name:
Platiran
Other name:
Platistin
Other name:
Platosin
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Doxorubicin Hydrochloride
Description:
Given IV
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
Other name:
ADM
Other name:
Adriacin
Other name:
Adriamycin
Other name:
Adriamycin Hydrochloride
Other name:
Adriamycin PFS
Other name:
Adriamycin RDF
Other name:
ADRIAMYCIN, HYDROCHLORIDE
Other name:
Adriamycine
Other name:
Adriblastina
Other name:
Adriblastine
Other name:
Adrimedac
Other name:
Chloridrato de Doxorrubicina
Other name:
DOX
Other name:
DOXO-CELL
Other name:
Doxolem
Other name:
Doxorubicin HCl
Other name:
Doxorubicin.HCl
Other name:
Doxorubin
Other name:
Farmiblastina
Other name:
FI 106
Other name:
FI-106
Other name:
FI106
Other name:
hydroxydaunorubicin
Other name:
Rubex
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
Given IV
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Abitrexate
Other name:
Alpha-Methopterin
Other name:
Amethopterin
Other name:
Brimexate
Other name:
CL 14377
Other name:
CL-14377
Other name:
Emtexate
Other name:
Emthexat
Other name:
Emthexate
Other name:
Farmitrexat
Other name:
Fauldexato
Other name:
Folex
Other name:
Folex PFS
Other name:
Lantarel
Other name:
Ledertrexate
Other name:
Lumexon
Other name:
Maxtrex
Other name:
Medsatrexate
Other name:
Metex
Other name:
Methoblastin
Other name:
Methotrexate LPF
Other name:
Methotrexate Methylaminopterin
Other name:
Methotrexatum
Other name:
Metotrexato
Other name:
Metrotex
Other name:
Mexate
Other name:
Mexate-AQ
Other name:
MTX
Other name:
Novatrex
Other name:
Rheumatrex
Other name:
Texate
Other name:
Tremetex
Other name:
Trexeron
Other name:
Trixilem
Other name:
WR-19039
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo surgery
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, NOS
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo X-ray
Arm group label:
Efficacy Phase Arm A (MAP)
Arm group label:
Efficacy Phase Arm B (cabozantinib, MAP)
Arm group label:
Efficacy Phase Arm C (MAP)
Arm group label:
Efficacy Phase Arm D (cabozantinib, MAP)
Arm group label:
Feasibility phase (cabozantinib, MAP)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiographic imaging procedure (procedure)
Other name:
Radiography
Other name:
RG
Other name:
Static X-Ray
Other name:
X-Ray
Summary:
This phase II/III trial tests the safety, side effects, and best dose of the drug
cabozantinib in combination with standard chemotherapy, and to compare the effect of
adding cabozantinib to standard chemotherapy alone in treating patients with newly
diagnosed osteosarcoma. Cabozantinib is in a class of medications called kinase
inhibitors which block protein signals affecting new blood vessel formation and the
ability to activate growth signaling pathways. This may help slow the growth of tumor
cells. The drugs used in standard chemotherapy for this trial are methotrexate,
doxorubicin, and cisplatin (MAP). Methotrexate stops cells from making DNA and may kill
tumor cells. It is a type of antimetabolite. Doxorubicin is in a class of medications
called anthracyclines. It works by slowing or stopping the growth of tumor cells in the
body. Cisplatin is in a class of medications known as platinum-containing compounds. It
works by killing, stopping or slowing the growth of tumor cells. Adding cabozantinib to
standard chemotherapy may work better in treating newly diagnosed osteosarcoma.
Detailed description:
PRIMARY OBJECTIVES:
I. To determine the feasibility of adding cabozantinib S-malate (cabozantinib) to
standard MAP (high dose methotrexate, doxorubicin hydrochloride [doxorubicin], and
cisplatin) chemotherapy in patients with newly diagnosed metastatic osteosarcoma with a
resectable primary tumor.
II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable
event-free survival (EFS) than MAP chemotherapy alone in patients with localized,
resectable osteosarcoma.
III. To determine whether MAP chemotherapy plus cabozantinib results in more favorable
event-free survival (EFS) than MAP chemotherapy alone in patients with metastatic, pelvic
and unresectable osteosarcoma.
SECONDARY OBJECTIVES:
I. To determine whether MAP chemotherapy plus cabozantinib results in more favorable
overall survival (OS) than MAP chemotherapy alone in patients with localized, resectable
osteosarcoma.
II. To determine whether MAP chemotherapy plus cabozantinib results in more favorable
overall survival (OS) than MAP chemotherapy alone in patients with metastatic, pelvic and
unresectable osteosarcoma.
EXPLORATORY OBJECTIVES:
I. To determine the rate of good histologic response (> 90%) of resected primary tumor
specimens following neoadjuvant chemotherapy with MAP plus cabozantinib and compare with
response rates for MAP chemotherapy alone.
II. To describe the toxicities of the addition of cabozantinib to MAP chemotherapy in
patients with newly diagnosed osteosarcoma.
III. To describe frequency of application of local control methods (surgery,
hypofractionated stereotactic body radiotherapy, or radiofrequency ablation) for
extrapulmonary metastatic osteosarcoma.
IV. To compare total cumulative delivered doses of MAP chemotherapy agents between
standard and experimental arms across multiple phases of therapy.
V. To assess the pharmacokinetics of cabozantinib when administered concomitantly with
standard chemotherapy agents during feasibility.
VI. To collect pulmonary metastatic lesions, paired primary tumor tissue, and serial
blood samples for tumor profiling, liquid biopsies, and future testing of correlative
biology studies.
OUTLINE: This is a dose-escalation study of cabozantinib (Feasibility Phase) followed by
a randomized phase II/III study (Efficacy Phase).
FEASIBILITY PHASE: Patients receive cabozantinib orally (PO), methotrexate intravenously
(IV), doxorubicin IV, and cisplatin IV for two 35-day "induction" cycles. Patients are
then considered for appropriate local control. Then they receive "consolidation" with
methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle, followed by
cabozantinib PO, methotrexate IV, doxorubicin IV, and cisplatin IV for one 35-day cycle,
and cabozantinib PO, methotrexate IV, and doxorubicin IV for two 35-day cycles. Patients
then receive cabozantinib PO for six 28-day "maintenance" cycles.
EFFICACY PHASE: Patients with standard risk osteosarcoma are randomized to Arm A or Arm
B. Patients with high risk osteosarcoma are randomized to Arm C or Arm D.
ARM A: Standard risk patients receive methotrexate IV, doxorubicin IV, and cisplatin IV
for two 35-day "induction" cycles, followed by appropriate local control. Patients then
receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for two
35-day cycles and methotrexate IV and doxorubicin IV for two additional 35-day cycles.
ARM B: Standard risk patients receive cabozantinib PO, methotrexate IV, doxorubicin IV,
and cisplatin IV for two 35-day "induction" cycles, followed by appropriate local
control. Patients then receive "consolidation" with cabozantinib PO, methotrexate IV,
doxorubicin IV, and cisplatin IV for two 35-day "consolidation" cycles, and cabozantinib
PO, methotrexate IV, and doxorubicin IV for two additional 35-day cycles. Patients then
receive cabozantinib PO for six 28-day "maintenance" cycles.
ARM C: High risk patients receive methotrexate IV, doxorubicin IV, and cisplatin IV for
two 35-day "induction" cycles, followed by appropriate local control. Patients then
receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin IV for two
35-day cycles and methotrexate IV and doxorubicin IV for two additional 35-day cycles.
ARM D: High risk patients receive cabozantinib PO, methotrexate IV, doxorubicin IV, and
cisplatin IV for two 35-day "induction" cycles, followed by appropriate local control.
Patients then receive "consolidation" with methotrexate IV, doxorubicin IV, and cisplatin
IV for one 35-day cycle, followed by cabozantinib PO, methotrexate IV, doxorubicin IV,
and cisplatin IV for one 35-day cycle and cabozantinib PO, methotrexate IV, and
doxorubicin IV for two additional 35-day cycles. Patients then receive cabozantinib PO
for six 28-day "maintenance" cycles.
All patients also undergo X-ray, computed tomography (CT), magnetic resonance imaging
(MRI), and positron emission tomography (PET) or bone scintigraphy at diagnosis and
additonal time points throughout the trial. All patients also undergo collection of blood
samples during screening and on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must be < 40 years of age at the time of enrollment.
- Patients must have a body surface area of >= 0.8 m^2 at the time of enrollment.
- Patients must have histologic diagnosis (by institutional pathologist) of newly
diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites
are eligible as long as diagnosis of high-grade osteosarcoma is established.
Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic
chemotherapies.
- Feasibility Phase:
Patients must have metastatic disease and a resectable primary tumor. Designation of a
primary tumor as resectable will be determined at the time of diagnosis by the
institutional multidisciplinary team.
For this study, metastatic disease is defined as one or more of the following:
- Lesions which are discontinuous from the primary tumor, are not regional lymph
nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions
in the same bone as the primary tumor do not constitute metastatic disease. Skip
lesions in an adjacent bone are considered bone metastases.
- Lung metastases: defined as biopsy-proven metastasis or the presence of one or more
pulmonary lesions >= 5 mm, OR multiple pulmonary lesions >= 3 mm or greater in size.
- Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18
(18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone
scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory
biopsy or supportive anatomic imaging of at least one suspicious site with either
magnetic resonance imaging (MRI) or computed tomography (CT) (whole body
18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable).
- Efficacy Phases (Phase 2/3)
Patients with both localized and metastatic disease are eligible for the efficacy phase,
regardless of resectability. Patients will be enrolled to two separate cohorts:
- Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be
resectable at the time of diagnosis by the institutional multidisciplinary team,
without evidence of metastatic lesions.
- Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor
designated as unresectable by the institutional multidisciplinary team, AND/OR
radiographic evidence of metastatic lesions.
- A serum creatinine based on age/gender as follows (within 7 days prior to
enrollment unless otherwise indicated):
- (Age: Maximum Serum Creatinine [mg/dL]; Gender)
- 1 month to < 6 months: 0.4 (male); 0.4 (female)
- 6 months to < 1 year: 0.5 (male); 0.5 (female)
- 1 to < 2 years: 0.6 (male); 0.6 (female)
- 2 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: 1.7 (male); 1.4 (female)
- OR - a 24 hour urine creatinine clearance >= 70 mL/min/1.73 m^2
- OR - a glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2. GFR must be performed
using direct measurement with a nuclear blood sampling method OR direct small
molecule clearance method (iothalamate or other molecule per institutional
standard).
- Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates
are not acceptable for determining eligibility.
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7
days prior to enrollment unless otherwise indicated)
- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase
[ALT]) =< 135 U/L (within 7 days prior to enrollment unless otherwise
indicated)
- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the
value of 45 U/L
- No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart
Association (NYHA) Class III or IV congestive heart failure, unstable angina
pectoris, serious cardiac arrhythmias or
- Shortening fraction of >= 27%, or
- Ejection fraction of >= 50%, or
- Corrected QT interval by Fridericia (QTcF) < 480 msec on electrocardiogram. Patients
with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have
correctable causes of prolonged QTc addressed if possible (i.e., electrolytes,
medications).
- Peripheral absolute neutrophil count (ANC) >= 1000/uL (within 7 days prior to
enrollment unless otherwise indicated)
- Platelet count >= 100,000/uL (transfusion independent, defined as not receiving
platelet transfusions within a 7-day period prior to enrollment) (within 7 days
prior to enrollment unless otherwise indicated)
- Hemoglobin >= 8.0 g/dL (within 7 days prior to enrollment unless otherwise
indicated)
- International normalized ratio (INR) =< 1.5 (within 7 days prior to enrollment
unless otherwise indicated)
- Human immunodeficiency virus (HIV)-infected patients on effective
anti-retroviral therapy with undetectable viral load within 6 months are
eligible as long as they are NOT receiving anti-retroviral agents that are
strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter
protein.
- 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.
Exclusion Criteria:
- Patients who have received previous systemic therapy for osteosarcoma or a prior
oncologic diagnosis.
- Patients who have central nervous system metastases.
- Patients with central cavitating pulmonary lesions invading or encasing any major
blood vessels in the lung.
- Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed.
- Patients with gastrointestinal disorders including active disorders associated with
a high risk of perforation or fistula formation. Specifically, no clinically
significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction,
intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis
or other signs of pulmonary hemorrhage for 3 months prior to enrollment.
- Patients with active bleeding or bleeding diathesis. No clinically significant
hematuria, hematemesis, or hemoptysis or other history of significant bleeding
within 3 months prior to enrollment.
- Patients with uncompensated or symptomatic hypothyroidism. Patients who have
hypothyroidism controlled with thyroid replacement hormone are eligible.
- Patients with moderate to severe hepatic impairment (Child-Pugh B or C).
- Patients who have had primary tumor resection or attempted curative resection of
metastases prior to enrollment.
- Patients who have undergone other major surgical procedure (eg, laparotomy) within
14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes
(biopsy of lung nodule) and central access such as port-a-cath placement are
allowed.
- Patients with a history of serious or non-healing wound or bone fracture (pathologic
fracture of primary tumor is not considered exclusion).
- Patients with any medical or surgical conditions that would interfere with
gastrointestinal absorption of cabozantinib.
- Patients with previously identify allergy or hypersensitivity to components of the
study treatment formulations.
- Patients who are receiving any other investigational agent not defined within this
protocol 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.
- Patients who received enzyme-inducing anticonvulsants within 14 days prior to
enrollment.
- Patients with a prior history of hypertension (> 95th percentile for age, height,
and gender for patients < 18 years and > 140/90 mmHg for patients >= 18 years
requiring medication for blood pressure control.
- Patients who are receiving drugs that prolong QTc.
- Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct
thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or
platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per
local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are
permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa
inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose
for at least 6 weeks before the first dose of study treatment, and who have had no
complications from a thromboembolic event or the anticoagulation regimen.
- Patients receiving strong CYP3A4 inducers or strong CYP3A4 inhibitors.
- 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 protocol therapy.
Gender:
All
Minimum age:
N/A
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Facility:
Name:
Arkansas Children's Hospital
Address:
City:
Little Rock
Zip:
72202-3591
Country:
United States
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Loma Linda University Medical Center
Address:
City:
Loma Linda
Zip:
92354
Country:
United States
Facility:
Name:
Miller Children's and Women's Hospital Long Beach
Address:
City:
Long Beach
Zip:
90806
Country:
United States
Facility:
Name:
Valley Children's Hospital
Address:
City:
Madera
Zip:
93636
Country:
United States
Facility:
Name:
UCSF Benioff Children's Hospital Oakland
Address:
City:
Oakland
Zip:
94609
Country:
United States
Facility:
Name:
Kaiser Permanente-Oakland
Address:
City:
Oakland
Zip:
94611
Country:
United States
Facility:
Name:
Children's Hospital of Orange County
Address:
City:
Orange
Zip:
92868
Country:
United States
Facility:
Name:
Lucile Packard Children's Hospital Stanford University
Address:
City:
Palo Alto
Zip:
94304
Country:
United States
Facility:
Name:
Rady Children's Hospital - San Diego
Address:
City:
San Diego
Zip:
92123
Country:
United States
Facility:
Name:
UCSF Medical Center-Mission Bay
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Facility:
Name:
University of Florida Health Science Center - Gainesville
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Facility:
Name:
Nemours Children's Clinic-Jacksonville
Address:
City:
Jacksonville
Zip:
32207
Country:
United States
Facility:
Name:
Nicklaus Children's Hospital
Address:
City:
Miami
Zip:
33155
Country:
United States
Facility:
Name:
AdventHealth Orlando
Address:
City:
Orlando
Zip:
32803
Country:
United States
Facility:
Name:
Kapiolani Medical Center for Women and Children
Address:
City:
Honolulu
Zip:
96826
Country:
United States
Facility:
Name:
Lurie Children's Hospital-Chicago
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Riley Hospital for Children
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Facility:
Name:
University of Iowa/Holden Comprehensive Cancer Center
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Facility:
Name:
University of Kentucky/Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Facility:
Name:
Norton Children's Hospital
Address:
City:
Louisville
Zip:
40202
Country:
United States
Facility:
Name:
Ochsner Medical Center Jefferson
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Facility:
Name:
Maine Children's Cancer Program
Address:
City:
Scarborough
Zip:
04074
Country:
United States
Facility:
Name:
Sinai Hospital of Baltimore
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
Children's Hospital of Michigan
Address:
City:
Detroit
Zip:
48201
Country:
United States
Facility:
Name:
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Facility:
Name:
University of Minnesota/Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Facility:
Name:
Children's Mercy Hospitals and Clinics
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Children's Hospital and Medical Center of Omaha
Address:
City:
Omaha
Zip:
68114
Country:
United States
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Facility:
Name:
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Address:
City:
Las Vegas
Zip:
89135
Country:
United States
Facility:
Name:
Summerlin Hospital Medical Center
Address:
City:
Las Vegas
Zip:
89144
Country:
United States
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Facility:
Name:
Morristown Medical Center
Address:
City:
Morristown
Zip:
07960
Country:
United States
Facility:
Name:
Newark Beth Israel Medical Center
Address:
City:
Newark
Zip:
07112
Country:
United States
Facility:
Name:
Saint Joseph's Regional Medical Center
Address:
City:
Paterson
Zip:
07503
Country:
United States
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Facility:
Name:
Montefiore Medical Center - Moses Campus
Address:
City:
Bronx
Zip:
10467
Country:
United States
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Facility:
Name:
NYU Langone Hospital - Long Island
Address:
City:
Mineola
Zip:
11501
Country:
United States
Facility:
Name:
Stony Brook University Medical Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Facility:
Name:
State University of New York Upstate Medical University
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Facility:
Name:
New York Medical College
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Facility:
Name:
East Carolina University
Address:
City:
Greenville
Zip:
27834
Country:
United States
Facility:
Name:
Wake Forest University Health Sciences
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Facility:
Name:
Rainbow Babies and Childrens Hospital
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
Dayton Children's Hospital
Address:
City:
Dayton
Zip:
45404
Country:
United States
Facility:
Name:
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Address:
City:
Toledo
Zip:
43606
Country:
United States
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Saint Christopher's Hospital for Children
Address:
City:
Philadelphia
Zip:
19134
Country:
United States
Facility:
Name:
Children's Hospital of Pittsburgh of UPMC
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Facility:
Name:
Prisma Health Richland Hospital
Address:
City:
Columbia
Zip:
29203
Country:
United States
Facility:
Name:
Saint Francis Hospital
Address:
City:
Greenville
Zip:
29601
Country:
United States
Facility:
Name:
BI-LO Charities Children's Cancer Center
Address:
City:
Greenville
Zip:
29605
Country:
United States
Facility:
Name:
Saint Francis Cancer Center
Address:
City:
Greenville
Zip:
29607
Country:
United States
Facility:
Name:
Sanford USD Medical Center - Sioux Falls
Address:
City:
Sioux Falls
Zip:
57117-5134
Country:
United States
Facility:
Name:
Saint Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Facility:
Name:
The Children's Hospital at TriStar Centennial
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Facility:
Name:
Dell Children's Medical Center of Central Texas
Address:
City:
Austin
Zip:
78723
Country:
United States
Facility:
Name:
Medical City Dallas Hospital
Address:
City:
Dallas
Zip:
75230
Country:
United States
Facility:
Name:
UT Southwestern/Simmons Cancer Center-Dallas
Address:
City:
Dallas
Zip:
75390
Country:
United States
Facility:
Name:
El Paso Children's Hospital
Address:
City:
El Paso
Zip:
79905
Country:
United States
Facility:
Name:
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Covenant Children's Hospital
Address:
City:
Lubbock
Zip:
79410
Country:
United States
Facility:
Name:
UMC Cancer Center / UMC Health System
Address:
City:
Lubbock
Zip:
79415
Country:
United States
Facility:
Name:
Children's Hospital of San Antonio
Address:
City:
San Antonio
Zip:
78207
Country:
United States
Facility:
Name:
Methodist Children's Hospital of South Texas
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
University of Texas Health Science Center at San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Facility:
Name:
Primary Children's Hospital
Address:
City:
Salt Lake City
Zip:
84113
Country:
United States
Facility:
Name:
University of Virginia Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Facility:
Name:
Children's Hospital of The King's Daughters
Address:
City:
Norfolk
Zip:
23507
Country:
United States
Facility:
Name:
VCU Massey Cancer Center at Stony Point
Address:
City:
Richmond
Zip:
23235
Country:
United States
Facility:
Name:
Virginia Commonwealth University/Massey Cancer Center
Address:
City:
Richmond
Zip:
23298
Country:
United States
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Facility:
Name:
Providence Sacred Heart Medical Center and Children's Hospital
Address:
City:
Spokane
Zip:
99204
Country:
United States
Facility:
Name:
Mary Bridge Children's Hospital and Health Center
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Facility:
Name:
Madigan Army Medical Center
Address:
City:
Tacoma
Zip:
98431
Country:
United States
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Start date:
March 3, 2023
Completion date:
March 20, 2030
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05691478
