Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823950
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Mississippi Medical Center

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.

Condition or disease Intervention/treatment Phase
Granulocyte Colony-Stimulating Factor Chemotherapy-induced Neutropenia Chemotherapy-Induced Febrile Neutropenia Pediatric Cancer Drug: Granulocyte Colony-Stimulating Factor Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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 Name: 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.



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Duration of neutropenia [ 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 ]
    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

  2. Days delayed in beginning the next course of chemotherapy [ Time Frame: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year ]
    A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia


Other Outcome Measures:
  1. Needle distress [ Time Frame: 2 days ]
    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. Physical Side Effects [ Time Frame: 1 week ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823950


Contacts
Layout table for location contacts
Contact: Jessica M Seaborn, MD 601-984-5221 jseaborn@umc.edu
Contact: Anderson B Collier, MD 601-984-5221 acollier@umc.edu

Locations
Layout table for location information
United States, Mississippi
Univeristy of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Jessica M Seaborn, MD    601-984-5221    jseaborn@umc.edu   
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Anderson B Collier, MD University of Mississippi Medical Center

Layout table for additonal information
Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT03823950     History of Changes
Other Study ID Numbers: 2018-0082
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Febrile Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Sargramostim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs