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A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma


Phase 2
N/A
30 Years
Open (Enrolling)
Both
Osteosarcoma, Malignant Fibrous Histiocytoma (MFH) of Bone

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Trial Information

A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Description:

To study the feasibility of combining bevacizumab (AvastinĀ®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), with cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) in patients with localized resectable osteosarcoma, and bevacizumab with cisplatin, doxorubicin, HDMTX, ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Fariba Navid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

OS2008

NCT ID:

NCT00667342

Start Date:

May 2008

Completion Date:

May 2015

Related Keywords:

  • Osteosarcoma
  • Malignant Fibrous Histiocytoma (MFH) of Bone
  • Histiocytoma
  • Osteosarcoma
  • Histiocytoma, Benign Fibrous
  • Histiocytoma, Malignant Fibrous

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
St Jude Children's Research HospitalMemphis, Tennessee  38105
Rady Children's Hospital and Health CenterSan Diego, California  92123
Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231
NCI/NIH - Pediatric Oncology BranchBethesda, Maryland  20892