Clinical Trial: Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Ost
Brief Summary: 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.
Detailed Summary:
This study has multiple research objectives:
- 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
- To continue the evaluation of dynamic contrast-enhanced magnetic resonance imaging (DEMRI) in predicting tumor response and accurately assessing the degree of response (continued from OS-91).
- To determine the feasibility of delivering outpatient-based chemotherapy for osteosarcoma using ifosfamide-doxorubicin-carboplatin.
- To determine whether resection of the primary site may be satisfactorily performed with a 3 cm margin of normal bone (rather than 5 cm).
- To study biologic and biochemical characteristics of the tumor cells that may be of prognostic significance
- To study the patients' and parents' perspectives of the patients' quality of life during and after treatment.
Description of Treatment Plan:
This study employs the following treatment strategy: neoadjuvant chemotherapy followed by definitive surgery for local control and adjuvant chemotherapy after tumor resection.
Pre-operative chemotherapy phase (weeks 0-12): Three courses of ifosfamide/carboplatin given every 3 weeks followed by one 3-week course of doxorubicin.Disease evaluation is performed after 3 courses and after 4 courses of chemotherapy.
Weeks 0, 3, and 6 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily o
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome: Histologic response rate [ Time Frame: After all patients have undergone definitive surgery and become evaluable for histologic response evaluation. ]
Original Primary Outcome:
- To compare the tumor response to chemotherapy with three drugs(ifosfamide, carboplatin, and doxorubicin)used before surgery in an earlier St.Jude Children's Research Hospital study.
- To study the accuracy of dynamic contrast-enhanced MR imaging in assessing the degree of response.
Current Secondary Outcome:
Original Secondary Outcome:
- To study the feasibility of administering therapy on an outpatient basis.
- To study whether a 3-cm surgical margin of normal bone (rather than the 5-cm standard margin)provides satisfactory
- resection of the primary tumor.
- To study biological markers including telomerase activity and DNA index.
- To learn what subjects and parents think about the of life during and after treatment
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: September 1, 2005
Date Started: May 1999
Date Completion:
Last Updated: June 8, 2011
Last Verified: June 2011
