Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2004-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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trastuzumab

Intervention Type BIOLOGICAL

conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No