A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

This study has been terminated.
(Accrual goal met)
Sponsor:
Information provided by (Responsible Party):
Edmund Waller, Emory University
ClinicalTrials.gov Identifier:
NCT00646763
First received: March 25, 2008
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.


Condition Intervention Phase
Cytokines
Drug: G-CSF, GM-CSF administered at extremities
Drug: G-CSF and GMCSF administered at abdomen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The Total Number of CD34+ Cells Collected. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Number of Participants for Whom Target Number of CD34+ Cells Were Collected. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment


Secondary Outcome Measures:
  • Total Number of Days of Apheresis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    the number of days of apheresis required to collect target numbers of CD34+ cells.


Enrollment: 35
Study Start Date: April 2008
Study Completion Date: February 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Abdomen
These subjects will have their cytokine injections administered only to their abdomen.
Drug: G-CSF and GMCSF administered at abdomen
Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.
Other Name: Neupogen, Leukine, growth factors
Active Comparator: Extremities
The extremity arm will have their injections administered to their upper and/or lower extremities.
Drug: G-CSF, GM-CSF administered at extremities
Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.
Other Name: Neupogen, Leukine, growth factors

Detailed Description:

The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

Exclusion Criteria:

  • Patients with active, invasive/systemic fungal infection.
  • Patients who are pregnant or lactating females.
  • Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
  • Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646763

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Edmund Waller, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Edmund Waller, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00646763     History of Changes
Other Study ID Numbers: IRB00007445, 7445
Study First Received: March 25, 2008
Results First Received: March 14, 2012
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lenograstim
Mitogens
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014