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Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00005033
Collaborator
National Cancer Institute (NCI) (NIH)
4
Locations
56
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: trastuzumab
  • Procedure: conventional surgery
 Phase 2

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
Study Start Date :
Dec 1, 1999
Actual Study Completion Date :
Aug 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    2 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
    3 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    4 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005033
    Other Study ID Numbers:
    • CDR0000067558
    • MSKCC-99097
    • NCI-T98-0083
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 21, 2013
    Last Verified:
    Aug 1, 2004
    Keywords provided by , ,
    recurrent osteosarcoma
    Additional relevant MeSH terms:
    Osteosarcoma
    Trastuzumab

    Study Results

    No Results Posted as of Jun 21, 2013