Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma - Full Text View

Sponsors and Collaborators:	St. Jude Children's Research Hospital Immunex/Berlex National Institutes of Health (NIH)
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00145639

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 II

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma

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

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Najat C Daw, MD

St. Jude Children's Research Hospital

More Information

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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:	St.Jude Children's Research Hospital ( Najat Daw, M.D./Principal Investigator )
Study ID Numbers:	OS99
Study First Received:	September 1, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00145639
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

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ifosfamide
Malignant mesenchymal tumor
Sarcoma
Osteosarcoma

Carboplatin
Osteogenic sarcoma
Doxorubicin
Soft tissue sarcomas
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009