Tissue Repair in Stem Cell Transplant Recipients - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Amgen
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00501228

Purpose

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.

Condition	Intervention
Graft-Versus-Host Disease	Drug: Filgrastim

Drug Information available for: Filgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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). [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	5
Study Start Date:	February 2003
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Filgrastim	Drug: Filgrastim 5 mg/kg ID Once Daily x 1 Week

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
Donors and patients must be of different gender.
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.
The only acceptable consent form is the one attached at the end of this protocol.
Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.

Exclusion Criteria:

Patients who are allergic to rhG-CSF.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501228

Locations

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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Amgen

Investigators

Principal Investigator:

Martin J. Korbling, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Martin J. Korbling, MD/Professor )
Study ID Numbers:	ID02-300
Study First Received:	July 12, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00501228
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Graft-Versus-Host Disease
Stem Cell Transplantation
Tissue Repair

Organ-Specific Tissue Damage
Filgrastim
RhG-CSF

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009