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

Not Recruiting

Trial ID: NCT00742924


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.

Official Title

Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Stanford Investigator(s)



   - 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


   - 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

   - 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


   - No prior chemotherapy or radiotherapy

   - No other concurrent anticancer chemotherapy

   - No concurrent immunomodulating agents

   - Steroids for anti-emetic allowed


drug: cisplatin

drug: dexrazoxane hydrochloride

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: leucovorin calcium

drug: methotrexate

drug: zoledronic acid

procedure: adjuvant therapy

procedure: neoadjuvant therapy

procedure: therapeutic conventional surgery

biological: filgrastim

drug: Mesna

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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