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 range
2 Years – 18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.