Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma
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.
Timeline
- Start
- 1999-05
- Primary completion
- 2006-05
- Completion
- 2006-05
Publications
- Background Crews KR, Stewart CF, Liu T, Rodriguez-Galindo C, Santana VM, Daw NC. Effect of fractionated ifosfamide on the pharmacokinetics of irinotecan in pediatric patients with osteosarcoma. J Pediatr Hematol Oncol. 2004 Nov;26(11):764-7. doi: 10.1097/00043426-200411000-00016.
- Background Sanders RP, Drissi R, Billups CA, Daw NC, Valentine MB, Dome JS. Telomerase expression predicts unfavorable outcome in osteosarcoma. J Clin Oncol. 2004 Sep 15;22(18):3790-7. doi: 10.1200/JCO.2004.03.043.
- Background McCarville MB, Barton EH, Cameron JR, Xiong X, Daw NC, Kaste SC, Wu S, Glass JO, Reddick WE. The cause and clinical significance of central tumor photopenia on thallium scintigraphy of pediatric osteosarcoma of the extremity. AJR Am J Roentgenol. 2007 Feb;188(2):572-8. doi: 10.2214/AJR.06.0292.
- Background Freeman SS, Allen SW, Ganti R, Wu J, Ma J, Su X, Neale G, Dalton J, Billups C, Dome JS, Daw NC, Khoury JD. Osteosarcoma tumors commonly express EGFR and harbor frequent gains at the EGFR locus and losses at the PTEN Locus. Clin Cancer Res (Submitted).
- Background Rivera GK, Quintana J, Villarroel M, Santana VM, Rodriguez-Galindo C, Neel MD, Velez G, Ribeiro RC, Daw NC. Transfer of complex frontline anticancer therapy to a developing country: the St. Jude osteosarcoma experience in Chile. Pediatr Blood Cancer. 2008 Jun;50(6):1143-6. doi: 10.1002/pbc.21444.
- Background McCarville MB, Romano E, Daw N, Xiong X, Reddick W, Kaste S. Etiology of the 201Thallium
- Background McCarville MB, Reddick WE, Xiong X, Kaste SC, Daw NC. Clinical significance of the 201Thallium donut-sign in primary extremity osteosarcoma. Presented at the 2006 Society of Pediatric Radiology and European Society of Paediatric Radiology's Fifth Conjoint Meeting, Montreal, Quebec, Canada, May 18-20, 2006.
- Background Kaste SC, Waszilycsak G, McCarville MB, Daw NC. Excess cancer mortality in pediatric thallium imaging. Presented at the 2006 Society of Pediatric Radiology and European Society of Paediatric Radiology's Fifth Conjoint Meeting, Montreal, Quebec, Canada, May 18-20, 2006.
- Background Freeman SS, Allen SW, Ganti R, Wu J, Ma J, Su X, Neale GA, Dalton JD, Billups CA, Dome JS, Daw NC, Khoury JD. EGFR expression and copy number gain are common in osteosarcoma. Presented at the US and Canadian Academy of Pathology Annual Meeting, San Diego, California, March 24-30, 2007.
- Background Reddick WE, Hoffer FA, Billups CA, Jenkins JJ, Wu J, Daw NC. Response assessment using dynamic MR imaging in non-metastatic osteosarcoma. To be presented at the ASCO Annual Meeting, Chicago, Illinois, June 2007.
- Background Rivera GK, Quintana J, Villarroel M, Rodríguez C, Santana VM, Ribeiro RC, Daw NC. Conduct of an international collaborative osteosarcoma trial at centers in a developed and developing country. To be presented at the ASCO Annual Meeting, Chicago, Illinois, June 2007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Ifosfamide | Small molecule | 2650 mg/m2 | Intravenous |