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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

Must not have

Age < 2yrs and >12yrs old

AML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, the day of the procedure, after taking study medication.

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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 below

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My child is 2-12 years old, in remission from leukemia or lymphoma, and receiving maintenance chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am older than 12 years but younger than 2 years.

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I have been diagnosed with acute myeloid leukemia (AML).

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I am taking medications like fluconazole, amiodarone, or oxandrolone.

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I am on high doses of methotrexate.

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My child has cancer that does not involve the blood.

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My child is only having a bone marrow aspiration.

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I have taken celecoxib in the last 7 days.

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I have had peptic ulcers in the past.

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I am currently taking rifampin or phenobarbital.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, the day of the procedure, after taking study medication. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Awards & Highlights

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.

Trial 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.

0 / 10Eligibility criteria met