Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Liposomal doxorubicin
Isophosphamide mustard
Ifosfamide
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 11, 2014