Tissue Repair in Stem Cell Transplant Recipients
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.
1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients|
- Number of Donor Derived Cells After G-CSF Therapy [ Time Frame: Baseline + 8 Weeks post transplant ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2003|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Experimental: Filgrastim Injections||
5 mg/kg ID Once Daily x 1 Week
Other Name: RhG-CSF
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501228
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Martin J. Korbling, MD||M.D. Anderson Cancer Center|