AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors (NCT00985868) | Clinical Trial Compass
CompletedPhase 1
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
United Kingdom33 participantsStarted 2009-09
Plain-language summary
RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children and adolescents with relapsed and refractory solid tumors.
Who can participate
Age range2 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …