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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

All Genders

Up to 40 years

Phase:

PHASE1

Brief 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 ch...

Detailed Description

OBJECTIVES: Primary: * To assess the feasibility and safety of zoledronic acid when administered in combination with standard chemotherapy in patients with newly diagnosed metastatic osteosarcoma. *...

Eligibility Criteria

Inclusion

  • 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:
  • 4 mg/dL (for patients 1 to 5 months of age)
  • 5 mg/dL (for patients 6 to 11 months of age)
  • 6 mg/dL (for patients 1 year of age)
  • 8 mg/dL (for patients 2 to 5 years of age)
  • 1 mg/dL (for patients 6 to 9 years of age)
  • 2 mg/dL (for patients 10 to 12 years of age)
  • 5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00742924

    Start Date

    August 1 2008

    Last Update

    July 4 2014

    Active Locations (88)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 22 (88 locations)

    1

    UAB Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205

    3

    Southern California Permanente Medical Group

    Downey, California, United States, 90027

    4

    Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, United States, 90801