Trastuzumab in Treating Patients With Recurrent Osteosarcoma
RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma|
|Study Start Date:||December 1999|
|Study Completion Date:||August 2004|
- Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin).
- Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin.
OUTLINE: This is a multicenter study.
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate.
Patients are followed for 1 year for survival.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Study Chair:||Paul A. Meyers, MD||Memorial Sloan-Kettering Cancer Center|