Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Methotrexate

Criteria

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