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

Status unconfirmed · Phase 4

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

In brief

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.

Key facts

Study ID

NCT03823950

Run by

University of Mississippi Medical Center

People needed

150

Starts

2019-02-01

Expected to finish

2022-06-01

Last updated by the study team

2020-03-13

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Univeristy of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)

Full record on ClinicalTrials.gov

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