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The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.
1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will be that standard therapy + aprepitant is superior at preventing CINV than standard therapy + placebo.
1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy + placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron, dexamethasone, aprepitant | Experimental | Arm A: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily. |
|
| Ondansetron, Dexamethasone, placebo | Placebo Comparator | Arm B: Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron, dexamethasone, aprepitant | Drug | Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of aprepitant (Emend®) measured through a complete response | • Percentage of study subjects who demonstrate a complete response, defined as no episodes of emesis and no use of rescue medications during the investigational antiemetic cycles. | Up to 11 weeks, or until 3 weeks after the second course of the study regimen |
| Efficacy of aprepitant (Emend®) measured through episodes of emesis and use of rescue medication. |
| Up to 11 weeks, or until 3 weeks after the second course of the study regimen |
| Efficacy of aprepitant (Emend®) measured through impact of chemotherapy induced nausea and vomiting on daily life | • A modified, 5-day recall version of the Functional Living Index-Emesis (FLIE) questionnaire | Up to 11 weeks, or until 3 weeks after the second course of the study regimen |
| Efficacy of aprepitant (Emend®) measured through a pictorial nausea scale | • A modified version of the Baxter Animated Retching Faces (BARF) scale, administered daily. | Up to 11 weeks, or until 3 weeks after the second course of the study regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of aprepitant (Emend®) |
|
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Inclusion Criteria:
under 20.99 years of age at enrollment
Scheduled to receive two identical cycles of highly emetogenic[1] chemotherapy for treatment of a primary malignancy, including:
Chemotherapy with any one or more of the following single agents in any combination:
Or any of the following defined combinations:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene McNall-Knapp, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jimmy Everest Center for Cancer and Blood Disorders in Children | Oklahoma City | Oklahoma | 73104 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2021 | |
| Reset | Apr 20, 2021 | |
| Release | May 3, 2022 | |
| Reset | May 26, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2021 | Apr 20, 2021 | |||
| May 3, 2022 |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Ondansetron, Dexamethasone, placebo | Drug | Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%. |
|
|
| Up to 11 weeks, or until 3 weeks after the second course of the study regimen |
| May 26, 2022 |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009025 | Morpholines |
| D010078 | Oxazines |