Osteosarcoma1999-A Study Of Intensive Chemotherapy for Osteosarcoma
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ClinicalTrials.gov Identifier: NCT00145639 |
Recruitment Status
:
Completed
First Posted
: September 5, 2005
Last Update Posted
: June 10, 2011
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Condition or disease | Intervention/treatment | Phase |
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Osteosarcoma | Drug: Ifosfamide, Carboplatin, Doxorubicin Procedure: Limb Sparing | Phase 2 |

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 ifosfamide/carboplatin given every 3 weeks followed by one 3-week course of doxorubicin.Disease evaluation is performed after 3 courses and after 4 courses of chemotherapy.
Weeks 0, 3, and 6 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 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 mg/mL/min, given IV over 1 hour (Day 1 only)
Week 9- Evaluation, followed by Doxorubicin Doxorubicin: 25 mg/m2 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: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Week 17 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1 hour (Day 1 only)
Week 20 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Week 23 - Evaluation, followed by Ifosfamide:
Doxorubicin. Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Week 26 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1 hour (Day 1 only)
Week 29 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Week 32 - Evaluation, followed by Ifosfamide-Doxorubicin. Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Week 35 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | May 1999 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | May 2006 |
Arm | Intervention/treatment |
---|---|
1 |
Drug: Ifosfamide, Carboplatin, Doxorubicin
See Detailed Description for treatment plan.
Procedure: Limb Sparing
See Detailed Description for treatment plan.
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- Histologic response rate [ Time Frame: After all patients have undergone definitive surgery and become evaluable for histologic response evaluation. ]

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Ages Eligible for Study: | up to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145639
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 |
Principal Investigator: | Fariba Navid, MD | St. Jude Children's Research Hospital |
Additional Information:
Publications:
Responsible Party: | Fariba Navid, M.D., St.Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00145639 History of Changes |
Other Study ID Numbers: |
OS99 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | June 10, 2011 |
Last Verified: | June 2011 |
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 Liposomal doxorubicin Isophosphamide mustard Carboplatin |
Doxorubicin Ifosfamide Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |