A Pilot Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response
- Must be between 2 and 35 years of age at time of diagnosis
- Must have biopsy-proven, high-grade osteosarcoma.
- Patients with metastases are eligible as long as the lung is the only site of
- The primary tumor and all pulmonary metastases must be deemed to be potentially
resectable. There must be a commitment by the surgical team to resect the primary
tumor at week 12, and pulmonary nodules at any point, unless the clinical situation
indicates these interventions are not in the patient's best interest.
- Patients must have normal laboratory values and cardiac function as defined below:
- Creatinine clearance or radioisotope GFR of > or equal to 70ml/min/1.73 m2 OR
A serum creatinine based on age/gender as follows:
Age Maximum Serum Creatinine (mg/dL) Male Female
1 month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5
1. to < 2 years 0.6 0.6
2. to < 6 years 0.8 0.8
6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16
years 1.5 1.4
- or equal to 16 years 1.7 1.4
- Cardiac: Adequate cardiac function is defined as:
Shortening fraction of > or equal to 28% by echocardiogram OR Ejection fraction of > or
equal to 50% by radionuclide angiogram
- Hepatic: Adequate liver function is described as:
Total bilirubin of < or equal to 1.5 x upper limit of normal (ULN) for age
- Hematologic function: adequate hematologic function is defined as:
ANC > or equal to 1.5 x 10^9/L and platelet count > or equal to 100 x 10^9/L
- Female patients must have a negative pregnancy test
- Female patients who are lactating must agree to stop breast-feeding.
- Patients must not be known to be HIV positive. Testing for HIV is not mandatory.
- Sexually active patients of childbearing potential must agree to use effective
- Patients must be able to cooperate fully with all planned protocol therapy.
- Signed informed consent MUST be obtained from patient or parent/legal guardian prior
to any study procedures and study entry.
- Patients with any low-grade osteosarcoma, post-radiation osteosarcoma, and
osteosarcoma associated with Paget's disease are not eligible.
- Patients with metastases other than lung metastases are not eligible.
- Patients may not have received prior chemotherapy.