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Investigator(s):
Lee J. Helman, M.D. Principal Investigator Phone: 301-496-4257 helmanl@mail.nih.gov	Su Young Kim, M.D. Protocol Chair Phone: 301-451-7918 kimsuyou@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)	Lauren Meyerson Long, R.N. Research Nurse Phone: 301-496-0486 longl@mail.nih.gov

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Primary Eligibility:

• Recurrent osteosarcoma, localized to the lung
• Recurrence following standard chemotherapy including: adriamycin, cisplatin, ifosphamide, and methotrexate (or justification why any of these agents were not received)
• Must have had complete surgical removal of all lung nodules or be deemed fully resectable
• ≥ 15 years of age and < 75 years of age
• Weight > 34 kg
• ECOG performance score of 0–2
• ANC ≥ 1,500/μL, Hb ≥ 9 g/dL
• Platelets ≥ 100,000 μL
• Serum creatinine ≤ 1.5 or a creatinine clearance ≥ 50 L/min/l.73m²
• ALT/AST ≤ 2.5 x normal, total bilirubin ≤ 2 mg/dL with the exception of patients with Gilbert’s syndrome
• ECHO or MUGA with shortening fraction ≥ 27% (or ejection fraction ≥ 45%) and EKG with QTc ≤ 480 msec
• Not pregnant or nursing; must use acceptable method of contraception during participation in the study and for 3 months after the last dose
• Randomization must occur ≤ 6 weeks after complete surgical resection of all tumor nodules
• No metastatic disease in other locations in addition to the lung
• No disruption of the lung pleura by tumor
• No Paget's disease
• No use of medications that are potent inducers, inhibitors or substrates of CYP3A4
• No known hypersensitivity to other Src/Abl non-receptor kinase inhibitors
• No evidence of interstitial lung disease (bilateral, diffuse parenchymal lung disease)
• No medical condition that would preclude study participation
• Recovered from prior therapy
• ≥ 28 days since last administration of any biological or investigational agent or chemotherapy

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Study Outline:

This is a multi-institutional study.

• After complete resection of all lung nodules, patients will be randomized to treatment with AZDO53O or placebo
• Eighty-eight patients will be randomized, 44 patients in each arm of the study
• AZDO53O or placebo will be administered as a once-daily oral dose of 175 mg for a 28-day cycle, with no breaks between cycles
• The duration of treatment with AZDO53O or placebo will be 13 cycles (364 days total)
• Patients will begin Cycle 1 after complete surgical resection

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.

Reviewed: 
Updated: 8/21/09