A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
Osteosarcoma, Malignant Fibrous Histiocytoma (MFH) of Bone
About this trial
This is an interventional treatment trial for Osteosarcoma
Eligibility Criteria
Inclusion Criteria:
- Patient must have newly diagnosed high-grade, biopsy proven, osteosarcoma or malignant fibrous histiocytoma (MFH) of bone with no history of prior chemotherapy or radiation;
- Participant is able to perform tasks and daily activities as defined in the study guidelines
- Patient meets established guidelines for adequate function of the kidney, liver, heart and bone marrow
- Participants meets other requirements defined in the eligibility portion of the study
Exclusion Criteria:
- recent major surgical procedure or injury
- Known bleeding diathesis, platelet disorder or coagulopathy
- Thrombosis
- Cardiac disease or hypertension
- Significant proteinuria
- Central nervous system disease
- Gastrointestinal perforation/abdominal fistula
- Osteosarcoma or MFH of bone as second malignancy
Sites / Locations
- Rady Children's Hospital and Health Center
- Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
- NCI/NIH - Pediatric Oncology Branch
- St Jude Children's Research Hospital
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Localized Resectable Disease (Stratum A)
Metastatic Disease (Stratum B)
Unresectable Disease (Stratum C)
Participants with localized resectable disease receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin, and doxorubicin, or methotrexate. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, or methotrexate.
Participants with metastatic disease (Stratum B) receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively.
Participants with unresectable disease (Stratum C) receive treatment identical to Stratum B: Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively.