Understanding how celecoxib works in children's bodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the pharmacokinetics of celecoxib, a medication used for pain relief, specifically in children aged 2-12 undergoing chemotherapy for hematological malignancies. It aims to understand how genetic variations affect the metabolism of celecoxib and its impact on drug levels in the blood and cerebrospinal fluid. By comparing the effects of celecoxib to a placebo, the study seeks to determine appropriate dosing strategies for pediatric patients. The research will also explore how celecoxib may influence the central nervous system effects of other medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Children aged 2-12 years, undergoing Maintenance phase chemotherapy for hematological malignancies and lymphomas (i.e. acute lymphoblastic leukemia \[ALL\] and lymphoblastic lymphomas \[LLy\] at CHEO. At this point, all patients would have achieved remission an average of 6 months earlier.

Exclusion Criteria:

1. Age \< 2yrs and \>12yrs old
2. Children with non-hematologic malignancies
3. AML
4. Children undergoing a bone marrow aspiration (BMA) only
5. Serum creatinine \> 2 X UNL (upper normal limit) within 30 days
6. Abnormal liver function; alanine aminotransferase (ALT) \> 2 X UNL, Aspartate aminotransferase (AST) \> 2 X UNL, total \& direct bilirubin \> 2 X UNL within 30 days
7. History of peptic ulcer disease
8. Allergy to celecoxib or NSAIDs (note: sulpha allergy does not exclude celecoxib)
9. Recent (within 7 days) celecoxib ingestion
10. Patients receiving CYP2C9 inhibitors fluconazole, amiodarone, oxandrolone
11. Patients receiving CYP2C9 inducers rifampin and phenobarbitol
12. Patients receiving high (≥ 5 gm/m2) and/ or escalating doses of methotrexate.
13. Extremes of body mass index (BMI) (BMI \<5th percentile or \>95th percentile)
14. Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French
15. Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis or any impairment that would prohibit the understanding and giving of informed consent or study-related reporting
16. Patient enrolled in another trial
17. Pregnancy.

Where it's running

• Children's Hospital of Eastern Ontario
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Dr Kimmo Murto, MD — Children's Hospital of Eastern Ontario
• Study coordinator: Dr Kimmo Murto, MD
• Email: kmurto@cheo.on.ca
• Phone: 613-737-7600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.