Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00005033

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-12-31

Completion date

2004-08-31

Last updated

2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

recurrent osteosarcoma

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALtrastuzumab

PROCEDUREconventional surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026