AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors

• Status: Completed
• Trial end date: 2019-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK

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