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

University of Mississippi

Status and phase: Unknown; Phase 4

Conditions: Chemotherapy-Induced Febrile Neutropenia; Chemotherapy-induced Neutropenia; Pediatric Cancer; Granulocyte Colony-Stimulating Factor

Treatments: Drug: Granulocyte Colony-Stimulating Factor

Study type: Interventional

Funder types: Other

Identifiers

NCT03823950

2018-0082

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Receive G-CSF 72 hours following chemotherapy

Experimental group

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.

Treatment:

Drug: Granulocyte Colony-Stimulating Factor

Historical Controls

No Intervention group

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.