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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital Genentech National Institutes of Health (NIH) |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00667342 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma Malignant Fibrous Histiocytoma (MFH) of Bone |
Biological: Bevacizumab Drug: Chemotherapy (Cisplatin, Doxorubicin, Methotrexate, Ifosfamide, Etoposide) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma |
| Estimated Enrollment: | 95 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
See intervention description
|
Biological: Bevacizumab
Monoclonal Antibody against VEGF
Drug: Chemotherapy (Cisplatin, Doxorubicin, Methotrexate, Ifosfamide, Etoposide)
Cisplatin, Doxorubicin, Methotrexate, Ifosfamide, Etoposide
|
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:
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.
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Najat C Daw, MD | 1-866-278-5833 | info@stjude.org |
| United States, California | |
| Rady Children's Hospital and Health Center | Not yet recruiting |
| San Diego, California, United States, 92123 | |
| Contact: Jennifer Reikes Willert, MD | |
| United States, Maryland | |
| NCI/NIH - Pediatric Oncology Branch | Not yet recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Su Young Kim, MD, PhD | |
| Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: David M Loeb, PhD | |
| United States, Tennessee | |
| St Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | Najat C Daw, MD | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( Najat C. Daw, MD/Principal Investigator ) |
| Study ID Numbers: | OS2008 |
| Study First Received: | April 24, 2008 |
| Last Updated: | February 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00667342 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Histiocytoma, Malignant Fibrous Immunologic Factors Histiocytoma, Benign Fibrous Bevacizumab Etoposide phosphate Malignant Fibrous Histiocytoma Antibodies, Monoclonal Anti-Bacterial Agents Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Cisplatin Osteogenic Sarcoma Methotrexate Mitogens |
Alkylating Agents Etoposide Immunoglobulins Osteosarcoma Folic Acid Antagonists Endothelial Growth Factors Angiogenesis Inhibitors Immunosuppressive Agents Doxorubicin Folic Acid Ifosfamide Malignant Mesenchymal Tumor Antibodies Histiocytoma Radiation-Sensitizing Agents |
|
Antimetabolites Histiocytoma, Malignant Fibrous Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Histiocytoma, Benign Fibrous Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Bevacizumab Antibiotics, Antineoplastic Antibodies, Monoclonal Neoplasms, Connective and Soft Tissue Cisplatin Therapeutic Uses |
Abortifacient Agents Methotrexate Growth Inhibitors Angiogenesis Modulating Agents Dermatologic Agents Alkylating Agents Etoposide Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Growth Substances Osteosarcoma Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Angiogenesis Inhibitors |
