Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of chemotherapy with or without trastuzumab in treating patients who have metastatic osteosarcoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Leucovorin; Levoleucovorin; Liposomal doxorubicin; Methotrexate; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed high-grade osteosarcoma

• Metastatic

• Newly diagnosed

• No osteosarcoma arising in areas of Paget's disease or radiotherapy-induced sarcoma

• Presenting with at least 1 of the following:

• Bone metastases with or without lung metastases

• Bilateral lung metastases (any number of nodules)

• Unilateral lung metastases with at least 4 nodules

• Planned resection of either the primary site or a metastatic site of disease after completion of induction therapy

• Must be currently enrolled on the tumor biology study COG-P9851

• Performance status - ECOG 0-2

• Performance status - Karnofsky 50-100% (over age 10)

• Performance status - Lansky 50-100% (age 10 and under)

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Bilirubin ≤ 1.5 times normal

• SGPT ≤ 3 times normal

• Creatinine ≤ 1.5 times normal

• Creatinine clearance or glomerular filtration rate ≥ 70 mL/min

• Shortening fraction ≥ 28% by echocardiogram

• Ejection fraction ≥ 50% by echocardiogram or MUGA

• No history of pericarditis, myocarditis, symptomatic arrhythmia, or conduction disturbances

• Normal organ function

• HIV negative

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No prior chemotherapy

• No prior radiotherapy

• See Disease Characteristics