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

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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.


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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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