Overview

This trial is active, not recruiting.

Conditions osteosarcoma, malignant fibrous histiocytoma (mfh) of bone
Treatments bevacizumab, chemotherapy (cisplatin, doxorubicin, methotrexate, ifosfamide, etoposide)
Phase phase 2
Target VEGF
Sponsor St. Jude Children's Research Hospital
Collaborator Genentech
Start date May 2008
End date May 2014
Trial size 95 participants
Trial identifier NCT00667342, GENENTECH PHARM, OS2008

Summary

This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
See intervention description.
bevacizumab
Monoclonal Antibody against VEGF
chemotherapy (cisplatin, doxorubicin, methotrexate, ifosfamide, etoposide)
Cisplatin, Doxorubicin, Methotrexate, Ifosfamide, Etoposide. Participants with resectable localized disease (Stratum A) only receive cisplatin, methotrexate and doxorubicin.

Primary Outcomes

Measure
Feasibility
time frame: 5 years
Event Free Survival compared to historical controls on the Intergroup Study 0133
time frame: 7 years

Secondary Outcomes

Measure
Histologic response in patients with localized resectable osteosarcoma compared to Intergroup Study 0133 patients
time frame: 5 years plus 6 cycles of chemotherapy
Event free survival of patients with osteosarcoma
time frame: 6 years
Overall survival of patients with osteosarcoma
time frame: 6 years
Event free survival in patients with localized resectable disease compared to OS99 protocol.
time frame: 6 years
Overall survival in patients with localized resectable disease compared to OS99 protocol.
time frame: 6 years

Eligibility Criteria

Male or female participants up to 30 years old.

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

Additional Information

Official title A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma
Principal investigator Fariba Navid, MD
Description This is a comprehensive study that uses a novel agent that targets angiogenesis (bevacizumab) in combination with conventional chemotherapy for the treatment of osteosarcoma. Bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (VEGF), has been shown to stop the growth of new blood vessels of tumors, both in the laboratory and in patients with other types of cancers. Bevacizumab has improved the effect of chemotherapy in adult patients with different types of cancer by increasing tumor response and increasing the chances of survival. This study has two main goals: - To find out if bevacizumab can be combined safely with chemotherapy for osteosarcoma - To find out if adding bevacizumab to chemotherapy will be beneficial in treating osteosarcoma. The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. After completion of active therapy, patient's response to therapy will be followed for approximately 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by St. Jude Children's Research Hospital.