Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
Collaborators:
Immunex/Berlex
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00145639
First received: September 1, 2005
Last updated: June 8, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Drug: Ifosfamide, Carboplatin, Doxorubicin Procedure: Limb Sparing |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma |
Resource links provided by NLM:
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- Histologic response rate [ Time Frame: After all patients have undergone definitive surgery and become evaluable for histologic response evaluation. ]
| Enrollment: | 80 |
| Study Start Date: | May 1999 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Ifosfamide, Carboplatin, Doxorubicin
See Detailed Description for treatment plan.
Procedure: Limb Sparing
See Detailed Description for treatment plan.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prior chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145639
Locations
| United States, Arkansas | |
| Arkansas Children's Hospital | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, Missouri | |
| Washington University Medical Center | |
| St.Louis, Missouri, United States, 63110 | |
| United States, Tennessee | |
| St.Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Chile | |
| Hospital Luis Calvo Mackenna | |
| Santiago, Chile | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Immunex/Berlex
Investigators
| Principal Investigator: | Fariba Navid, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
Publications:
McCarville MB, Barton EH, Romano E, Cameron J, Kaste SC, Daw NC, Wu S, Glass JO, Xiong X, Reddick WE. The etiology and clinical significance of the thallium donut sign in pediatric osteosarcoma of the extremity. Am J Roentgenol 188:572-578, 2007.
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.
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.
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.
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.
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.
| Responsible Party: | Fariba Navid, M.D., St.Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00145639 History of Changes |
| Other Study ID Numbers: | OS99 |
| Study First Received: | September 1, 2005 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Chile: Chilean Ministry of Health |
Keywords provided by St. Jude Children's Research Hospital:
|
Osteosarcoma Treatment, Carboplatin |
Additional relevant MeSH terms:
|
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Doxorubicin Isophosphamide mustard |
Ifosfamide Carboplatin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013