Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145639
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-09-01
Brief Title:
Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide Carboplatin and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 ifosfamidecarboplatin given every 3 weeks followed by one 3-week course of doxorubicinDisease evaluation is performed after 3 courses and after 4 courses of chemotherapy
Weeks 0 3 and 6 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin dose based on GFR and targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 9- Evaluation followed by Doxorubicin Doxorubicin 25 mgm2 IV over 1 hour daily x 3
Week 12 Evaluation followed by definitive Surgery Local control by amputation or limb-salvage procedure
Post-operative chemotherapy Weeks 14-35 Ifosfamide carboplatin and doxorubicin in two-agent pairs for approximately 35 weeks
Week 14 - Ifosfamide-Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 17 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 20 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 23 - Evaluation followed by Ifosfamide
Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 26 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 29 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 32 - Evaluation followed by Ifosfamide-Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 35 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
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 ifosfamidecarboplatin given every 3 weeks followed by one 3-week course of doxorubicinDisease evaluation is performed after 3 courses and after 4 courses of chemotherapy
Weeks 0 3 and 6 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin dose based on GFR and targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 9- Evaluation followed by Doxorubicin Doxorubicin 25 mgm2 IV over 1 hour daily x 3
Week 12 Evaluation followed by definitive Surgery Local control by amputation or limb-salvage procedure
Post-operative chemotherapy Weeks 14-35 Ifosfamide carboplatin and doxorubicin in two-agent pairs for approximately 35 weeks
Week 14 - Ifosfamide-Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 17 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 20 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 23 - Evaluation followed by Ifosfamide
Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 26 - Ifosfamide-Carboplatin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only
Week 29 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 32 - Evaluation followed by Ifosfamide-Doxorubicin Ifosfamide 265 gmm2 IV daily over 15-30 minutes x 3 Days 1 2 3 with MESNA Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Week 35 - Carboplatin-Doxorubicin Carboplatin targeted to an AUC of 8 mgmLmin given IV over 1 hour Day 1 only Doxorubicin 25 mgm2 IV over 1 hour daily x 2 Days 1 and 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None