Current Research: Pediatric Hematology-Oncology

AOST0331-- A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy.

Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.

This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma.

Eligibility

Patients may be eligible for this trial if:

• Must be ≥ 5 years and ≤ 40 years on date of diagnostic biopsy.
• Must have high grade osteosarcoma. This includes second malignancies.
• Submission of diagnostic biopsy for rapid central review of diagnostic biopsy materials is required
• The site of the primary tumor must be in:
  • Long bone of upper limb, scapula (C40.0)
  • Short bone of upper limb (C40.1)
  • Long bone of lower limb (C40.2)
  • Short bone of lower limb (C40.3)
  • Vertebral column (C41.2)
  • Ribs, sternum, clavicle (C41.3)
  • Pelvic bones, sacrum, coccyx (C41.4)
  • Craniofacial osteosarcoma is NOT included.
• Patients must have a Karnofsky score ≥ 50 or WHO/ECOG ≥ 2 for patients age ≥ 16, Lansky score ≥ 50 for patients age < 16 . Patients whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.
• No previous treatment for osteosarcoma or previous chemotherapy for any disease. Previous radiotherapy for a prior cancer (other than osteosarcoma) is permitted.
• Female patients must have a negative pregnancy test.
• Patients must not be known to be HIV positive.

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI);
  University College London Hospitals

Project Begin Date

• Sept 2007

Tentative Project End Date

• Jun 2010

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .