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


N/A
N/A
N/A
Not Enrolling
Both
Graft-Versus-Host Disease

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Donor Derived Cells After G-CSF Therapy

Outcome Description:

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.

Outcome Time Frame:

Baseline + 8 Weeks post transplant

Safety Issue:

No

Principal Investigator

Martin J. Korbling, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID02-300

NCT ID:

NCT00501228

Start Date:

February 2003

Completion Date:

September 2008

Related Keywords:

  • Graft-Versus-Host Disease
  • Graft-Versus-Host Disease
  • Stem Cell Transplantation
  • Tissue Repair
  • Organ-Specific Tissue Damage
  • Filgrastim
  • RhG-CSF
  • Graft vs Host Disease

Name

Location

U.T.M.D. Anderson Cancer Center Houston, Texas  77030