Status:

COMPLETED

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

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborating Sponsors:

Genentech, Inc.

Conditions:

Osteosarcoma

Malignant Fibrous Histiocytoma (MFH) of Bone

Eligibility:

All Genders

Up to 30 years

Phase:

PHASE2

Brief 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...

Detailed 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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 3 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2017

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT00667342

Start Date

June 3 2008

End Date

August 1 2017

Last Update

August 7 2023

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Rady Children's Hospital and Health Center

San Diego, California, United States, 92123

2

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

3

NCI/NIH - Pediatric Oncology Branch

Bethesda, Maryland, United States, 20892

4

St Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

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