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CompletedNCT00005033Updated Jun 21, 2013

Trastuzumab in Treating Patients With Recurrent Osteosarcoma

A Phase 2 interventional study of trastuzumab and conventional surgery in Sarcoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2013-06-21.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcoma

Keywords

  • recurrent osteosarcoma
03

In context

Sarcoma

1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

Browse Sarcoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

06

Study locations

4 sites
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105-2794, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005033
First posted
Jan 27, 2003
Start date
Dec 1999
Completion
Aug 2004
Last update
Jun 21, 2013

Study contacts

Paul A. Meyers, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2004. You cannot join it, but the record below documents what was studied.

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