Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium, Dietary; Cisplatin; Dexrazoxane; Diphosphonates; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Imidazole; Isophosphamide mustard; Lenograstim; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Mesna; Methotrexate; Razoxane; Zoledronic Acid

Criteria

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