CELECOXIB Plasma and Cerebral Spinal Fluid Pharmacokinetics in Children

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Celecoxib is effective for reducing postoperative pain in adults. Children use celecoxib more rapidly than adults and require higher doses. Celecoxib is partially metabolized in the liver by a certain enzyme. A person's genetic variation of this enzyme can influence how well their body uses Celecoxib. Furthermore, Celecoxib down-regulates P-glycoprotein (P-gp), a drug efflux transporter located at the blood brain barrier responsible for central nervous system (CNS) extrusion of ondansetron and possibly fentanyl; therefore celecoxib may augment the CNS effects of these drugs.

Understanding the blood and cerebrospinal fluid (CSF) profile of celecoxib in children and the influence of genetics on metabolism would help to develop appropriate celecoxib dosing in children for various treatment options.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Eastern Ontario
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

Children aged 2-18 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 >18yrs 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.