Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 4/21/2016 |
Start Date: | July 2003 |
End Date: | February 2009 |
This study is designed to test the safety and feasibility of the simultaneous administration
of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed
patients.
of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed
patients.
Inclusion Criteria:
- Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient
who have undergone a definitive surgical resection as their primary surgery are still
eligible for participation in this study.
- No prior chemotherapy or radiation therapy
- Adequate renal function: creatinine < or = to 1.5 upper limit of normal
- Adequate liver function as defined by bilirubin < or = to 1.5 X upper limit of normal
and AST < or = to 3 X upper limit of normal institutional range Adequate
hematopoietic function as defined by platelet count > or = to 100,000/ram3 an
absolute neutrophil count > or = to 1,000/mm3.
- Adequate cardiac function as defined by shortening fraction > or = to 28% by
echocardiogram OR ejection fraction > or = to 50% by radionuclide angiogram
- Performance status < or = to 2
Exclusion Criteria:
- Prior history of cancer
- Prior treatment for cancer
- Prior history of Paget's disease
- Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic
cardiac conduction abnormalities
- Pregnancy or breast feeding
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