Recruiting

Granulocyte Colony-Stimulating Factor vs. Chemotherapy

Sponsor:

University of Mississippi Medical Center

Code:

NCT03823950

Conditions

Granulocyte Colony-Stimulating Factor

Chemotherapy-induced Neutropenia

Chemotherapy-Induced Febrile Neutropenia

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Granulocyte Colony-Stimulating Factor

Study Details

Brief summary:

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.

Conditions

Granulocyte Colony-Stimulating Factor

Chemotherapy-induced Neutropenia

Chemotherapy-Induced Febrile Neutropenia

Pediatric Cancer

Study ID

NCT03823950

Start date

Feb 1, 2019

Status verified date

Mar, 2020

Completion date

Jun, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria:

1. are between the ages of birth and 21 years old
2. is diagnosed with an oncologic disease
3. is being treated at UMMC Children's Cancer Clinic
4. 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.
5. is within first four courses of chemotherapy treatment

Exclusion Criteria:

  • Patients will be excluded from the current study if:

1. 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.
2. are being treated for relapsed disease
3. has clinical evidence of bone marrow involvement

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Receive G-CSF 72 hours following chemotherapy

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.

no intervention: Historical Controls

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.

Interventions

Granulocyte Colony-Stimulating Factor

Begin G-CSF 72 hours following chemotherapy

Primary outcome measure

  • Incidence of hospital admissions for febrile neutropenia [ Time Frame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year ]

Central Contacts and Locations

Central contacts

Anderson B Collier, MD

601-984-5221acollier@umc.edu

Locations

Univeristy of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Jessica M Seaborn, MD

601-984-5221jseaborn@umc.edu

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

Mar 13, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2020-03-13.