Trastuzumab in Treating Patients With Recurrent Osteosarcoma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005033

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.

Condition	Intervention	Phase
Sarcoma	Biological: trastuzumab Procedure: conventional surgery	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

December 1999

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005033

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul A. Meyers, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067558, MSKCC-99097, NCI-T98-0083
Study First Received:	April 6, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005033 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent osteosarcoma

Study placed in the following topic categories:

Antibodies, Monoclonal
Neoplasms, Connective and Soft Tissue
Antibodies
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Trastuzumab

Sarcoma
Osteogenic Sarcoma
Osteosarcoma
Recurrence
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Sarcoma
Osteosarcoma
Neoplasms, Connective Tissue
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009