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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pediatric Cancer; Chemotherapy-Induced Febrile Neutropenia; Chemotherapy-induced Neutropenia; Granulocyte Colony-Stimulating Factor
• Intervention / Treatment: Drug: Granulocyte Colony-Stimulating Factor

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Univeristy of Mississippi Medical Center
      • Contact: Jessica M Seaborn, MD; Phone Number: 601-984-5221; Email: jseaborn@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Granulocyte Colony-Stimulating Factor; Begin G-CSF 72 hours following chemotherapy; Other Names: G-CSF
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle distress	Distress Rating Tool: The DRS version for 2-, 3-, and 4-year-olds has three faces with different facial expressions for children to point to the one that best matches how they feel. The version for 5- and 6-year-olds has a visual analog scale presented as a thermometer with a happy face drawn next to the 0 and a sad face drawn next to the 10. The DRT version for youth 7 to 18 years defines distress as 'worry, anxiety, sadness, or fear,' on a scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress). The adult DRS will be used for youth 19 to 21 years. Caregivers will rate their perception of their child's distress	2 days
Physical Side Effects	Memorial Symptom Assessment Scale: Physical and psychological symptoms; 8 items on 3-4 point scale (7-12 yrs) during past 2 days; 22 items on 4-5 point scale (10-14 yrs) during past week	1 week

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Investigators: Principal Investigator: Anderson B Collier, MD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: 2018-0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes