Clinical trial NCT03823950: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Granulocyte Colony-Stimulating Factor
Chemotherapy-induced Neutropenia
Chemotherapy-Induced Febrile Neutropenia
Pediatric Cancer
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 150
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Incidence of hospital admissions for febrile neutropenia
timeFrame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Secondary outcomes:
measure: Duration of neutropenia
timeFrame: 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
measure: Days delayed in beginning the next course of chemotherapy
timeFrame: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year
Other outcomes:
measure: Needle distress
timeFrame: 2 days
measure: Physical Side Effects
timeFrame: 1 week
Locations:
city: Jackson
country: United States
facility: Univeristy of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Anderson B Collier, MD
role: PRINCIPAL_INVESTIGATOR
References: