Understanding how celecoxib works in children's bodies

CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

This study is testing how the pain medication celecoxib works in children aged 2-12 who are getting chemotherapy to see how their bodies process it and how it affects their treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 2 Years to 12 Years
• Sex: All
• Sponsor: Children's Hospital of Eastern Ontario (other)
• Drugs / interventions: chemotherapy, methotrexate
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT01344200 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 2-12 years who are in the maintenance phase of chemotherapy for hematological malignancies.

Not a fit: Patients outside the age range of 2-12 years or those with non-hematologic malignancies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to optimized dosing of celecoxib in children, improving pain management during chemotherapy.

How similar studies have performed: While there have been studies on celecoxib in adults, this specific investigation in children is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Ottawa, Ontario

• 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

Conditions: Pharmacokinetics of Celecoxib in Children, Pharmacokinetics, Celecoxib, Children, Pharmacogenetic, ABCB1 genotype, CYP2C9 genotype, CSF