Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Trastuzumab in Treating Patients With Recurrent Osteosarcoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Any age | NCI | MSKCC-99097 NCI-T98-0083, T98-0083, NCT00005033 |
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.
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:
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 Lead Organizations
Memorial Sloan-Kettering Cancer Center
 | | | ||
| Paul Meyers, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma | |
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| Trial Start Date | 1999-12-07 | |
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| Registered in ClinicalTrials.gov | NCT00005033 | |
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| Date Submitted to PDQ | 2000-01-12 | |
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| Information Last Verified | 2004-08-11 | |
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| NCI Grant/Contract Number | P30-CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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