Clinical trial

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

Name

OS2008

Description

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.

Trial arms

Trial start

2008-06-03

Estimated PCD

2014-08-01

Trial end

2017-08-01

Status

Completed

Phase

Early phase I

Treatment

Bevacizumab

Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).

Arms:

Localized Resectable Disease (Stratum A), Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

rhuMAb VEGF, Avastin®

Cisplatin

Given IV.

Arms:

Localized Resectable Disease (Stratum A), Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

Platinol-AQ®

Doxorubicin

Given IV.

Arms:

Localized Resectable Disease (Stratum A), Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

Adriamycin®

Methotrexate

Given IV.

Arms:

Localized Resectable Disease (Stratum A), Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

MTX

Ifosfamide

Given IV.

Arms:

Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

Ifex®

etoposide

Given IV.

Arms:

Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Other names:

VP-16, Vepesid®

Surgery

Participants undergo definitive surgery and assessment of histologic response at week 10.

Arms:

Localized Resectable Disease (Stratum A), Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Radiotherapy

Radiation therapy delivered for positive margins or intralesional resections.

Arms:

Metastatic Disease (Stratum B), Unresectable Disease (Stratum C)

Size

Primary endpoint

Number of Participants With Unacceptable Toxicity

After all patients have completed therapy, up to 1 year after last patient is enrolled

3-Year Event Free Survival

After all patients have completed therapy, up to 4 years after last patient is enrolled

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

Updated at

2023-08-07

1 organization

1 product

5 drugs

2 indications

Organization

St. Jude Children's Research Hospital

Drug

Atezolizumab

Indication

Osteosarcoma