Clinical Trials

DISEASE CHARACTERISTICS:

• Biopsy-proven high-grade osteosarcoma within the past 6 weeks
  • Newly diagnosed disease
  • Metastatic disease
• Resectable disease OR expected to become resectable after initial chemotherapy
• Disease has arisen outside of areas of Paget's disease

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
  • 0.4 mg/dL (for patients 1 to 5 months of age)
  • 0.5 mg/dL (for patients 6 to 11 months of age)
  • 0.6 mg/dL (for patients 1 year of age)
  • 0.8 mg/dL (for patients 2 to 5 years of age)
  • 1 mg/dL (for patients 6 to 9 years of age)
  • 1.2 mg/dL (for patients 10 to 12 years of age)
  • 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
  • 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• AST or ALT < 2.5 times ULN for age
• Shortening fraction ≥ 28% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³ (transfusion independent)
• Hemoglobin ≥ 10 g/dL (RBC transfusion allowed)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use contraception
• No known HIV infection
• No history of pericarditis, myocarditis, symptomatic arrhythmia, or conduction disturbances

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy
• No other concurrent anticancer chemotherapy
• No concurrent immunomodulating agents
• Steroids for anti-emetic allowed