Study on Adding Cabozantinib to Chemotherapy for Newly Diagnosed Osteosarcoma

Program Overview

The purpose of this study is to evaluate if adding cabozantinib, a drug that blocks signals that help tumors grow, to standard chemotherapy can better treat newly diagnosed osteosarcoma. The standard chemotherapy drugs used in this trial are methotrexate, doxorubicin, and cisplatin. These drugs work by stopping cancer cells from growing and dividing. Researchers want to see if the combination of cabozantinib and these chemotherapy drugs can slow down or stop the growth of osteosarcoma more effectively than chemotherapy alone.

Description

The study is divided into two phases: a Feasibility Phase and an Efficacy Phase.

Feasibility Phase:

• This phase is closed to new participants. It tested the safety of adding cabozantinib to standard chemotherapy in patients with metastatic osteosarcoma that can be surgically removed.

Efficacy Phase:

• Patients with standard risk osteosarcoma are randomly assigned to receive either standard chemotherapy alone (Arm A) or standard chemotherapy plus cabozantinib (Arm B).
• Patients with high risk osteosarcoma are randomly assigned to receive either standard chemotherapy alone (Arm C) or standard chemotherapy plus cabozantinib (Arm D).

Treatment Details:

• Arm A and C (Standard Chemotherapy): Patients receive methotrexate, doxorubicin, and cisplatin in cycles, followed by surgery if needed.
• Arm B and D (Chemotherapy + Cabozantinib): Patients receive cabozantinib along with methotrexate, doxorubicin, and cisplatin in cycles, followed by surgery if needed. After initial treatment, patients continue with cabozantinib for maintenance.

Throughout the study, patients will undergo various scans and tests to monitor their response to treatment and overall health.

Eligibility Criteria

Locations