Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor

NCT02322151 | Completed

• 2 other identifiers: 15004715-CC-0047
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these studies, it is now recommended that a nursing mother should not breastfeed from the time she receives the first dose of the drug until 2 days after the final dose. Researchers want to study the amount of the drug and its effect on the cells present in donor blood and breast milk. They hope to better understand the effects of this drug on breast milk. Objectives: \- To understand the effects of filgrastim on breast milk. Eligibility: \- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding. Design:

• Participants will receive rGCSF daily for 5 days. They will have blood taken daily.
• Participants will get a freezer bag containing 10 sterile, labeled containers for breast milk collection.
• Participants will transfer some of the breast milk they pump into one of the containers. They will write the date and time the milk was collected on the container. They will freeze the samples. Any remaining milk should be disposed of.
• Participants will bring the samples to NIH on the day of their stem cell collection procedure.
• For days 1 and 2 after stem cell collection, participants will continue to collect and freeze breast milk samples and dispose of any remaining milk.
• For days 3 5 after stem cell collection, participants will collect and freeze samples. They can also resume normal breastfeeding.
• A research nurse will arrange to collect the samples.

Conditions

Normal Physiology

Keywords

Filgrastim; Neupogen; Transplant; Breast Feeding; Concentration

Outcome Measures

Primary Outcomes (1)

• Analysis of collected samples

  Within one year

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Shibata H, Yamane T, Aoyama Y, Nakamae H, Hasegawa T, Sakamoto C, Terada Y, Koh G, Hino M. Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003;110(4):200-1. doi: 10.1159/000074226. No abstract available.

  PMID: 14663166 BACKGROUND

• Kaida K, Ikegame K, Fujioka T, Taniguchi Y, Inoue T, Hasei H, Tamaki H, Yoshihara S, Kawase I, Ogawa H. Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007;118(3):176-7. doi: 10.1159/000109267. Epub 2007 Oct 3. No abstract available.

  PMID: 17914246 BACKGROUND

• Pessach I, Shimoni A, Nagler A. Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013 May-Jun;19(3):259-67. doi: 10.1093/humupd/dms053. Epub 2013 Jan 3.

  PMID: 23287427 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Kathleen A Conry Cantilena, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 23, 2014
• Study Start: December 12, 2014
• Primary Completion: November 9, 2015
• Study Completion: October 14, 2016
• Last Updated: December 16, 2019

Record last verified: 2016-10-14

Locations

US (1)