Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients

Study Overview
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Brief Summary
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Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.

Official Title
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A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients

Conditions
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Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia, Pediatric Cancer

Intervention / Treatment
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* Drug: Granulocyte Colony-Stimulating Factor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria: are between the ages of birth and 21 years old is diagnosed with an oncologic disease is being treated at UMMC Children's Cancer Clinic will receive G-CSF as part of their standard or experimental oncology treatment protocol between January 1, 2019 and December 31, 2019. Oncology treatment protocols are typically derived from the Children's Oncology Group standard of care or patients can be enrolled on a Children's Oncology Group treatment study. is within first four courses of chemotherapy treatment Exclusion Criteria: Patients will be excluded from the current study if: G-CSF was added to their oncology treatment protocol due to previous complications but for whom G-CSF was not part of their original treatment protocol. are being treated for relapsed disease has clinical evidence of bone marrow involvement

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receive G-CSF 72 hours following chemotherapy<br>Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit. Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy. | Drug: Granulocyte Colony-Stimulating Factor<br>* Begin G-CSF 72 hours following chemotherapy<br>* Other names: G-CSF;|
| No Intervention: Historical Controls<br>Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital admissions for febrile neutropenia | Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500 | From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of neutropenia | The number of days between the first documented ANC less than or equal to 500 and the first documented ANC greater than 500 following nadir | From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year | 
| Days delayed in beginning the next course of chemotherapy | A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia | Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year |