Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

Completed · Phase 2

Conditions studied: Osteosarcoma

In brief

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.

Key facts

Study ID

NCT00586846

Run by

Memorial Sloan Kettering Cancer Center

People needed

40

Starts

2003-07-01

Expected to finish

2009-02-01

Last updated by the study team

2016-01-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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