AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed solid tumor meeting 1 of the following criteria:
• •* Refractory to conventional treatment
• •* Disease for which no conventional therapy exists
• •Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for ≥ 1 week before study entry
• •PATIENT CHARACTERISTICS:
• •WHO performance status (PS) 0-2 OR Lansky Play PS 70-100% (\> 50% is acceptable if it is due to a stable neurological deficit or CNS tumor)
• •Life expectancy ≥ 12 weeks
• •ANC ≥ 1,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 9.0 g/dL
• •Serum bilirubin \< 1.5 times upper limit of normal (ULN)
• •Creatinine kinase normal
• •ALT or AST \< 2.5 times ULN (≤ 5 times ULN if due to tumor)
• •Creatinine clearance/EDTA-measured GFR ≥ 60 mL/min
• •Sufficient blood volume to undergo the blood-sampling regimen specified by the protocol that, in the opinion of the investigator, will not jeopardize patient's safety
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 6 months after completion of study therapy
• •Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection
• •Not known to be serologically positive for hepatitis B or C or HIV
• •Fractional shortening of \> 29% on echocardiogram
• •LVEF ≥ 50%
• •No history of allergy or auto-immune disease
• •No congenital heart disease
• •No other condition that, in the investigator's opinion, would not make the patient a good candidate for the clinical trial
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from prior therapy
• •More than 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for investigational medicinal products, 2 weeks for vincristine)
• •More than 3 months since prior autologous stem cell transplantation
• •No prior allogenic bone marrow transplantation
• •No prior extensive radiotherapy to \> 25% of bone marrow
• •No prior Aurora kinase inhibitor
• •No prior major thoracic or abdominal surgery from which the patient has not yet recovered
• •No prior or concurrent participation in another interventional clinical trial
• •* Participation in an observational study allowed
• •No other concurrent anticancer therapy or investigational drugs