Tissue Repair in Stem Cell Transplant Recipients

Graft-Versus-Host Disease Clinical Trial

Official title:

RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00501228
• Other study ID #: ID02-300
• Status: Terminated
• Phase: N/A
• First received: July 12, 2007
• Last updated: July 31, 2012
• Start date: February 2003
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.

Secondary Objective:

1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.

Description:

It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.

Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.

Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.

Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.

This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.

2. Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.

3. Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.

4. Donors and patients must be of different gender.

5. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.

6. The only acceptable consent form is the one attached at the end of this protocol.

7. Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.

Exclusion Criteria:

1. Patients who are allergic to rhG-CSF.

2. Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-Versus-Host Disease

Intervention

Drug:
• Filgrastim
5 mg/kg ID Once Daily x 1 Week

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Donor Derived Cells After G-CSF Therapy	In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.	Baseline + 8 Weeks post transplant	No

External Links

•   UT MD Anderson Cancer Center website