Overview

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (AvastinĀ®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborator:
Genentech, Inc.
Treatments:
Antibodies, Monoclonal
Bevacizumab
Cisplatin
Doxorubicin
Endothelial Growth Factors
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Methotrexate
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