Status:
COMPLETED
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
Lead Sponsor:
Cancer Research UK
Conditions:
Unspecified Childhood Solid Tumor, Protocol Specific
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief 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 childr...
Detailed Description
OBJECTIVES: Primary * To evaluate the safety and tolerability of Aurora kinase inhibitor AT9283 by characterizing the dose-limiting toxicities in children and adolescents with relapsed and refractor...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00985868
Start Date
September 1 2009
End Date
November 20 2019
Last Update
November 29 2019
Active Locations (5)
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1
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
2
Leeds General Infirmary
Leeds, England, United Kingdom, LS9 7TF
3
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
4
Great North Children's Hospital, Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom, NE1 4LP