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Nonsteroidal Anti-inflammatory Drug
Celecoxib for Pharmacokinetics of Celecoxib
Phase 2
Recruiting
Led By Dr Kimmo Murto, MD
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, the day of the procedure, after taking study medication.
Awards & highlights
Study Summary
This trial found that celecoxib is effective in reducing postoperative pain in adults, while children use celecoxib more rapidly and require higher doses.
Who is the study for?
This trial is for children aged 2-12 undergoing chemotherapy for certain blood cancers and in remission. They must not have kidney or liver issues, recent celecoxib use, be on conflicting medications, have a history of ulcers, extreme BMI, or other trials ongoing. Pregnant individuals or those with allergies to NSAIDs are excluded.Check my eligibility
What is being tested?
The study tests how Celecoxib behaves in the blood and cerebrospinal fluid of children and examines genetic factors affecting its metabolism. It compares Celecoxib's effects against a placebo to understand dosing for pain management post-surgery.See study design
What are the potential side effects?
Celecoxib may cause stomach problems like ulcers, increase risk of heart attack or stroke in adults (risk in children is unclear), allergic reactions, liver/kidney issues, and could potentially interact with other CNS drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is 2-12 years old, in remission from leukemia or lymphoma, and receiving maintenance chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, the day of the procedure, after taking study medication.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, the day of the procedure, after taking study medication.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Develop a PK model that explores the relationship between plasma and CSF celecoxib concentrations and the impact of covariates including age, weight and genetics using nonlinear mixed effects models.
Mean celecoxib CSF concentration (ug/L) at the following time intervals (mins): 0-60, 61-120,121-180,181-300, 301-900 and 901-1440.
Celecoxib
+1 moreSecondary outcome measures
Correlation between CSF and plasma study drug concentrations
Correlation with qualitative P-gp expression
Determine Area under the plasma concentration versus time curve (AUC)
+10 moreTrial Design
5Treatment groups
Active Control
Placebo Group
Group I: Phase II: Group B: Study drug (Celecoxib 7 mg/kg)Active Control1 Intervention
Study participants randomized to this group you will receive a single 7 mg/kg dose of celecoxib which will be in a liquid form, and the study participant will drink it.
The timing of when the study participant in this group will take this medication will be determined in a second randomization:
Group B.1: will take the study medication 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.
Group B.2: will take the study medication 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.
Group B.3: will take the study medication 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.
Group B.4: will take the study medication 1 to 2 hours prior to having their LP±BMA. The study medication will be taken at the hospital.
Group B.5: will take the study medication 0 to 60 minutes prior to having your LP±BMA. The study medication will be taken at the hospital.
Group II: Phase II: Group C: Study drug (Celecoxib 14 mg/kg)Active Control1 Intervention
Study participants randomized to this group you will receive a single 14 mg/kg dose of celecoxib which will be in a liquid form, and the study participant will drink it.
The timing of when the study participant in this group will take this medication will be determined in a second randomization:
Group C.1: will take the study medication 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.
Group C.2: will take the study medication 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.
Group C.3: will take the study medication 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.
Group C.4: will take the study medication 1 to 2 hours prior to having your LP±BMA. The study medication will be taken at the hospital.
Group C.5: will take the study medication 0 to 60 minutes prior to having your LP±BMA. The study medication will be taken at the hospital.
Group III: Phase I: Study drug Group 1 (Celecoxib 7 mg/kg)Active Control1 Intervention
Study participants randomized to this group will receive a single 7 mg/kg dose of celecoxib approximately 121-180 minutes before their scheduled LP ± BMA. The study medication will be a liquid and the study participant will be asked to drink it.
Group IV: Phase I: Study drug Group 2 (Celecoxib 14 mg/kg)Active Control1 Intervention
Study participants randomized to this group will receive a single 14 mg/kg dose of celecoxib approximately 121-180 minutes before their scheduled LP ± BMA. The study medication will be a liquid and the study participant will be asked to drink it.
Group V: Phase II: Group A: PlaceboPlacebo Group1 Intervention
Study participants will receive a single dose of placebo. Placebo will be liquid. The study participant will drink it.
The timing of when the study participants in this group will take placebo will be determined in a second randomization:
Group A.1: will take placebo 15 to 24 hours prior to having their LP±BMA. The study medication will be taken at home.
Group A.2: will take placebo 5 to 15 hours prior to having their LP±BMA. The study medication will be taken at home.
Group A.3: will take the placebo 3 to 5 hours prior to having their LP±BMA. The study medication will be taken at home.
Group A.4: will take the study medication 1 to 2 hours prior to having their LP±BMA. The study medication will be taken at the hospital.
Group A.5: will take the study medication 0 to 60 minutes prior to having their LP±BMA. The study medication will be taken at the hospital.
Find a Location
Who is running the clinical trial?
Children's Hospital of Eastern OntarioLead Sponsor
126 Previous Clinical Trials
55,369 Total Patients Enrolled
Dr Kimmo Murto, MDPrincipal InvestigatorChildren's Hospital of Eastern Ontario
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 12 years but younger than 2 years.My child is 2-12 years old, in remission from leukemia or lymphoma, and receiving maintenance chemotherapy.I have been diagnosed with acute myeloid leukemia (AML).My liver tests are more than twice the normal limit.I am taking medications like fluconazole, amiodarone, or oxandrolone.I am on high doses of methotrexate.My child has cancer that does not involve the blood.My child is only having a bone marrow aspiration.I have taken celecoxib in the last 7 days.I have had peptic ulcers in the past.I am currently taking rifampin or phenobarbital.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: Group B: Study drug (Celecoxib 7 mg/kg)
- Group 2: Phase II: Group C: Study drug (Celecoxib 14 mg/kg)
- Group 3: Phase I: Study drug Group 1 (Celecoxib 7 mg/kg)
- Group 4: Phase II: Group A: Placebo
- Group 5: Phase I: Study drug Group 2 (Celecoxib 14 mg/kg)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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