Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
N/A
N/A
Both
Sarcoma
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed recurrent osteosarcoma after initial systemic therapy with
doxorubicin
- Measurable disease
- Immunohistochemical evidence of 2+ overexpression of HER2
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- ALT or AST less than 3 times upper limit of normal (ULN)
- Bilirubin less than 1.5 times ULN
Renal:
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Fractional shortening at least 29% by echocardiogram OR
- Ejection fraction at least 50% by MUGA
- No prior cardiac dysfunction, even if presently controlled
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No prior anthracycline more than 450 mg/m^2
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No other concurrent cancer therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Paul A. Meyers, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067558
NCT ID:
NCT00005033
Start Date:
December 1999
Completion Date:
August 2004
Related Keywords:
- Sarcoma
- recurrent osteosarcoma
- Osteosarcoma
- Sarcoma
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 |
