Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Torrescano, Tanner; Frankos, Marie; Singh, Sarah H; Jones, Jamie
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-841-8271 ; 321-842-8738 ; 321.841.7561 ; 3218412008
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IRB No: C23.150.08
Protocol Abbrev: AOST2032
Principal Investigator:
Phase: Drug: Phase II
Age Group: Pediatric
Treatment: Procedure: Bone Scan, Drug: Cabozantinib S-malate, Drug: Cisplatin, Procedure: Computed Tomography, Drug: Doxorubicin Hydrochloride, Procedure: Magnetic Resonance Imaging, Drug: Methotrexate, Procedure: Surgical Procedure, Procedure: X-Ray Imaging
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05691478
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Objective
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. -
Key Eligibility
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.
