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Trastuzumab in Treating Patients With Recurrent Osteosarcoma
This study has been completed.
Study NCT00005033   Information provided by National Cancer Institute (NCI)
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes

April 6, 2000
February 6, 2009
December 1999
 
 
 
Complete list of historical versions of study NCT00005033 on ClinicalTrials.gov Archive Site
 
 
 
Trastuzumab in Treating Patients With Recurrent Osteosarcoma
Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma

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.

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.

Phase II
Interventional
Treatment
Sarcoma
  • Biological: trastuzumab
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005033
 
CDR0000067558, MSKCC-99097, NCI-T98-0083
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Paul A. Meyers, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP