Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00005033
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00005033
Study Brief:
Protocol Section:
NCT00005033