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

Cytokines Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00646763
• Other study ID #: IRB00007445
• Secondary ID: 7445
• Status: Terminated
• Phase: Phase 2
• First received: March 25, 2008
• Last updated: November 26, 2013
• Start date: April 2008
• Est. completion date: February 2011

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: February 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytokines

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Total Number of CD34+ Cells Collected.		4 days	No
Primary	Number of Participants for Whom Target Number of CD34+ Cells Were Collected.	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	7 days	No
Secondary	Total Number of Days of Apheresis	the number of days of apheresis required to collect target numbers of CD34+ cells.	7 days	No