Overview

Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma

Status:
Terminated
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy before and after surgery works in treating patients with osteosarcoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Calcium
Dexrazoxane
Doxorubicin
Leucovorin
Levoleucovorin
Liposomal doxorubicin
Methotrexate
Razoxane
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed osteosarcoma

- No more than 1 month since prior diagnostic biopsy

- Nonmetastatic malignant high-grade osteosarcoma of bone

- Histologically confirmed metastatic disease allowed

- Unresectable primary disease allowed

- No low-grade, parosteal, or periosteal osteosarcoma

PATIENT CHARACTERISTICS:

Age:

- 25 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8.0 g/dL

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT less than 5 times normal

Renal:

- Creatinine no greater than 1.5 times normal

- Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min

Cardiovascular:

- Shortening fraction at least 27% by echocardiogram or MUGA

- Ejection fraction at least 45% by echocardiogram or MUGA

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Other:

- No other concurrent therapy with no evidence of progressive disease