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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

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