Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
OBJECTIVES:
- 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.
Interventional
Primary Purpose: Treatment
Paul A. Meyers, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000067558
NCT00005033
December 1999
August 2004
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |