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

NCT03823950 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2018-0082
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year

Secondary Outcomes (2)

• Duration of neutropenia

  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

• Days delayed in beginning the next course of chemotherapy

  Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year

Other Outcomes (2)

• Needle distress

  2 days

• Physical Side Effects

  1 week

Study Arms (2)

Receive G-CSF 72 hours following chemotherapy

EXPERIMENTAL

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

Historical Controls

NO 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.

Interventions

Granulocyte Colony-Stimulating Factor DRUG

Begin G-CSF 72 hours following chemotherapy

Also known as: G-CSF

Receive G-CSF 72 hours following chemotherapy

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

Univeristy of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

MeSH Terms

Conditions

Chemotherapy-Induced Febrile Neutropenia; Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Febrile Neutropenia; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Anderson B Collier, MD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anderson B Collier, MD

CONTACT

601-984-5221; acollier@umc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 31, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)