Clinical trial NCT01896440: Heart Safety Study of Ondansetron in Children Receiving Chemotherapy
Official title: The Effects of Ondansetron on Myocardial Repolarization in Children Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Malignant Childhood Neoplasm
Keywords: Pediatric
Ondansetron
Cardiac repolarization
QTc interval
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We will study the effects of ondansetron on measurements of electrical activity in the heart to make sure doses we are using to prevent nausea and vomiting in children receiving chemotherapy are safe.

Detailed description: Children receiving chemotherapy for cancer at the Jimmy Everest Center for Cancer and Blood Disorders in Children also often receive an IV dose of an antiemetic for prophylaxis. The most common antiemetics used are in the family of 5HT3 antagonists, specifically granisetron and ondansetron. Prior to a recent recommendation by the FDA, we have used ondansetron 0.45 mg/kg IV. Based on adult ECG data, the recommended dose of ondansetron has been changed to no greater than 0.15 mg/kg. We have prior studies showing that the bigger dose is better at preventing nausea and vomiting. Therefore we are studying ECG data in patients receiving ondansetron and chemotherapy. Each subject will have two identical cycles of chemotherapy. Prior to the first of the two cycles they will be randomized to receive one of two doses of ondansetron with the first cycle and the other dose with the second cycle. The two doses are the recommended dose of 0.15 mg/kg and a higher dose of 0.3 mg/kg. The dose level the patient receives each cycle will be blinded to the investigator and the subject.

Prior to the first dose of investigational ondansetron, the patient will have an ECG. This ECG will be repeated 30 minutes after the ondansetron is administered and just before chemotherapy administration, and repeated again 30 minutes later. The change in the QTc intervals will be calculated by two independent pediatric cardiologists who are also blinded to the ondansetron dose level received. This process will be repeated with the next course of chemotherapy, with the second dose of ondansetron. Our goal is to see if there is an appreciable difference between the two doses in the QTc interval changes they induce.

Eligibility criteria: Inclusion Criteria:

* Age 6 months to 18 years
* Diagnosis of cancer and receiving 2 identical cycles of chemotherapy within 2 months of each other

Exclusion Criteria:

* History of cardiac conduction anomalies, myocardial infarction, structural heart abnormalities (even if repaired)
* Pregnant or of child-bearing age and unwilling to take a pregnancy test
* Potassium or calcium outside of reference range at screening
* Liver enzymes (AST/ALT) or bilirubin \>/= 2 x the upper limit of normal at screening

Primary outcomes:
measure: Change in QTc interval
timeFrame: Day 1 to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Rene Y McNall-Knapp, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Matthew Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: