New York, New York 10021

  • Sarcoma

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00005033


Primary Contact:

Study Chair
Paul A. Meyers, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 05, 2021

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