Status:
COMPLETED
Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...
Detailed Description
OBJECTIVES: * To evaluate the efficacy of a new induction regimen comprising ifosfamide in combination with high-dose methotrexate, cisplatin, and doxorubicin hydrochloride, in terms of clinical resp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed osteosarcoma of the extremity
- High-grade (grade III or IV) disease
- No low-grade disease (e.g., parosteal or periosteal osteosarcoma)
- No secondary osteosarcoma (i.e., tumor occurring in a radiotherapy field designed for a prior tumor)
- No Paget's disease
- No known metastases
- PATIENT CHARACTERISTICS:
- Total bilirubin \< 2 times normal
- AST \< 2 times normal
- Alkaline phosphatase \< 2 times normal
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min
- LVEF ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior malignancy except retinoblastoma
- Patients with familial retinoblastoma syndrome who develop osteosarcoma unrelated to radiotherapy (e.g., in a primary site in the extremities) are eligible
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- Patients with retinoblastoma may have received radiotherapy to the orbits
- At least 28 days since prior initial amputation
Exclusion
Key Trial Info
Start Date :
November 1 1990
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00645632
Start Date
November 1 1990
End Date
January 1 2008
Last Update
May 16 2011
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