RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Launched by THE HOSPITAL FOR SICK CHILDREN · Apr 13, 2017

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called olanzapine can help control nausea and vomiting caused by chemotherapy in children. Chemotherapy-induced vomiting (CIV) can be really uncomfortable for kids receiving treatment for cancer, even when they are given other medications to prevent it. The researchers believe that adding olanzapine to the usual anti-nausea medicines might provide better relief for these children, especially those receiving strong chemotherapy treatments.

To be part of this study, children aged 2.5 to 18 years who weigh at least 12.5 kg and are scheduled to receive specific types of strong chemotherapy are eligible. Participants will stay in the hospital for the first 24 hours after starting the study medication. During this time, they will receive regular anti-nausea medications, including ondansetron, to help manage any side effects. It's important for families to know that this trial requires participants to follow specific health guidelines, and parents or guardians will need to provide consent and ensure that their child can communicate in a language that the study materials are available in, like English, Spanish, or French.

Gender

ALL

Eligibility criteria

• • Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan \>140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose.
• • Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.
• • Body weight of at least 12.5 kg
• • 2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.
• Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose:
• • Plasma creatinine within 1.5 times the upper limit of normal for age.
• • Amylase within age-appropriate limits
• • Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome
• • ALT ≤ 5x upper limit of normal for age
• • Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc
• • A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.
• • Negative pregnancy test if female of childbearing potential
• • Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence
• • Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.
• • Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.