Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT00985868
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT00985868
Study Brief:
Protocol Section:
NCT00985868