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

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.

Conditions

• Sarcoma

Interventions

DRUG

cisplatin

Given IV

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

DRUG

leucovorin calcium

Given IV or orally

DRUG

methotrexate

Given IV

DRUG

zoledronic acid

Given IV

PROCEDURE

adjuvant therapy

PROCEDURE

neoadjuvant therapy

PROCEDURE

therapeutic conventional surgery

Surgery of the primary tumor is scheduled for 12 weeks after the commencement of chemotherapy.

BIOLOGICAL

filgrastim

Given SC

DRUG

Mesna

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Robert Goldsby, MD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2012-04-30

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations