Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Any age	NCI	MSKCC-99097 NCI-T98-0083, T98-0083, NCT00005033

Objectives

1. Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin).
2. Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin.

Entry Criteria

Disease Characteristics:

• Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin



• Measurable disease



• Immunohistochemical evidence of 2+ overexpression of HER2

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/m²

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent cancer therapy

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

Expected Enrollment

Approximately 20-40 patients will be accrued for this study within 2 years.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Paul Meyers, MD, Protocol chair		Ph: 212-639-5952; 800-525-2225 Email: meyersp@mskcc.org

Registry Information
Official Title		Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
Trial Start Date		1999-12-07
Registered in ClinicalTrials.gov		NCT00005033
Date Submitted to PDQ		2000-01-12
Information Last Verified		2004-08-11
NCI Grant/Contract Number		P30-CA08748

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