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

Primary Purpose

Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Granulocyte Colony-Stimulating Factor
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Granulocyte Colony-Stimulating Factor

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy of Mississippi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Receive G-CSF 72 hours following chemotherapy

Historical Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
January 8, 2019
Last Updated
March 11, 2020
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03823950
Brief Title
Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients
Official Title
A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia, Pediatric Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Receive G-CSF 72 hours following chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Historical Controls
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony-Stimulating Factor
Other Intervention Name(s)
G-CSF
Intervention Description
Begin G-CSF 72 hours following chemotherapy
Primary Outcome Measure Information:
Title
Incidence of hospital admissions for febrile neutropenia
Description
Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500
Time Frame
From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Secondary Outcome Measure Information:
Title
Duration of neutropenia
Description
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
Time Frame
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
Title
Days delayed in beginning the next course of chemotherapy
Description
A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia
Time Frame
Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year
Other Pre-specified Outcome Measures:
Title
Needle distress
Description
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
Time Frame
2 days
Title
Physical Side Effects
Description
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
Time Frame
1 week

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anderson B Collier, MD
Phone
601-984-5221
Email
acollier@umc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anderson B Collier, MD
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica M Seaborn, MD
Phone
601-984-5221
Email
jseaborn@umc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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