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

Part of paid clinical trials in San Diego, California.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT00667342
Phase
PHASE2
Status
Completed

Conditions

  • Malignant Fibrous Histiocytoma (MFH) of Bone
  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
  • Cisplatin — DRUG
    Given IV.
  • Doxorubicin — DRUG
    Given IV.
  • Methotrexate — DRUG
    Given IV.
  • Ifosfamide — DRUG
    Given IV.
  • etoposide — DRUG
    Given IV.
  • Surgery — PROCEDURE
    Participants undergo definitive surgery and assessment of histologic response at week 10.
  • Radiotherapy — RADIATION
    Radiation therapy delivered for positive margins or intralesional resections.

Study Details

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.

Key Dates

First listed
Apr 28, 2008
Start date
Jun 3, 2008
Status verified
May 2019
Primary completion
Aug 31, 2014
Completion
Aug 31, 2017

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Localized Resectable Disease (Stratum A)
    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.
  • Experimental: Metastatic Disease (Stratum B)
    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.
  • Experimental: Unresectable Disease (Stratum C)
    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.

Primary Outcome Measure

Number of Participants With Unacceptable Toxicity [ Time Frame: After all patients have completed therapy, up to 1 year after last patient is enrolled ]

Locations (5)

FacilityCityStateZIPSite coordinators
Rady Children's Hospital and Health CenterSan DiegoCalifornia92123-
Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
NCI/NIH - Pediatric Oncology BranchBethesdaMaryland20892-
St Jude Children's Research HospitalMemphisTennessee38105-
MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in San Diego, CA

By research site
Rady Children's Hospital and Health Center· San Diego, CAJohns Hopkins - Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDNCI/NIH - Pediatric Oncology Branch· Bethesda, MDSt Jude Children's Research Hospital· Memphis, TNMD Anderson Cancer Center· Houston, TX

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