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Growth Factor

Granulocyte Colony-Stimulating Factor for Pediatric Cancer

Phase 4
Waitlist Available
Led By Anderson B Collier, MD
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
is within first four courses of chemotherapy treatment
are between the ages of birth and 21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This study is evaluating whether a medication given after chemotherapy can help reduce the risk of infection.

Eligible Conditions
  • Pediatric Cancer
  • Febrile Neutropenia
  • Granulocyte Colony Stimulating Factor
  • Neutropenia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of hospital admissions for febrile neutropenia
Secondary outcome measures
Days delayed in beginning the next course of chemotherapy
Duration of neutropenia
Other outcome measures
Needle distress
Physical Side Effects

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03012672
50%
Febrile Neutropenia
30%
Hypoxia
27%
Pulmonary Edema
13%
Urinary Tract Infection
13%
Bacteremia
13%
Lung Infection
13%
Rash Maculo-Papular
13%
Respiratory Failure
10%
Soft Tissue Infection
10%
Hypotension
7%
Restrictive Cardiomyopathy
7%
Multi-organ failure
7%
Epistaxis
7%
Sepsis
7%
Acute Kidney Injury
7%
Cardiac Troponin I Increased
7%
Edema Limbs, Volume Overload
7%
Hyperglycemia
7%
Headache
3%
Mucositis
3%
Encephalopathy
3%
Pericardial Effusion
3%
Intracranial Hemorrhage
3%
Pneumonitis
3%
Tumor Lysis Syndrome
3%
COPD Exacerbation
3%
Anorexia
3%
Atrial Fibrillation
3%
Dyspnea
3%
AST/ALT Elevation
3%
Blood Bilirubin Increased
3%
Hyponatremia
3%
Pericarditis
3%
Pleural Effusion
3%
Blood Clot, Right Ear
3%
Catheter Related Infection
3%
Hypertension
3%
Hypokalemia
3%
Ejection Fraction Decreased
3%
Delirium
3%
Generalized Edema
3%
Paroxysmal Atrial Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ARM II (LOWER-DOSE):
ARM I (HIGHER-DOSE):

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Receive G-CSF 72 hours following chemotherapyExperimental Treatment1 Intervention
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.
Group II: Historical ControlsActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved

Find a Location

Who is running the clinical trial?

University of Mississippi Medical CenterLead Sponsor
171 Previous Clinical Trials
194,865 Total Patients Enrolled
Anderson B Collier, MDPrincipal InvestigatorUniversity of Mississippi Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~25 spots leftby Mar 2025