Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma

Completed · Phase 2

Conditions studied: Osteosarcoma

In brief

This trial (OS99) evaluates the use of ifosfamide, carboplatin, and doxorubicin in an up-front window before surgery for localized and resectable osteosarcoma. High-dose methotrexate, which may interfere with the dose-intensive delivery of other agents, is eliminated from the treatment of localized disease. The primary objective is to compare the response rate of pre-surgical chemotherapy comprised of ifosfamide, doxorubicin, and carboplatin to that obtained with ifosfamide and carboplatin in the St. Jude OS-91 trial for patients with non-metastatic resectable osteosarcoma. We hypothesize that the histologic response rate will be improved by the addition of one course of pre-operative chemotherapy on this trial compared to the previous OS-91 trial.

Key facts

Study ID: NCT00145639
Run by: St. Jude Children's Research Hospital
People needed: 80
Starts: 1999-05-01
Expected to finish: 2006-05-01
Last updated by the study team: 2011-06-10

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All subjects with histologically proven high-grade osteosarcoma,chondrosarcoma, MFH, fibrosarcoma or chondrosarcoma of bone, whose tumors are potentially resectable (either by limb sparing, en bloc resection, or amputation) and have no evidence of metastasis.
Adequate liver, renal and cardiac function.
Age: Younger than 25 years old

You may not qualify if…

Prior chemotherapy

Where it is running

Arkansas Children's Hospital — Little Rock, Arkansas, United States
Washington University Medical Center — St Louis, Missouri, United States
St.Jude Children's Research Hospital — Memphis, Tennessee, United States
Hospital Luis Calvo Mackenna — Santiago, Chile

Full record on ClinicalTrials.gov

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