This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.

Condition	Treatment or Intervention	Phase
Graft-vs-Host Disease	Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF)	Phase I Phase II

GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.

Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.

Ages Eligible for Study:  3 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
• Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
• Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
• Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion criteria:

• T-cell depletion for GVHD prophylaxis.
• Active hepatitis.
• Pre-existent inflammatory bowel disease requiring active therapy.
• Active uncontrolled infection.
• Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
• Documented hypersensitivity to rHuKGF.
• Prior enrollment to a study of rHuKGF.
• HIV-positive.
• Pregnant or nursing.
• Active chronic skin disease requiring therapy.

Michigan
      University of Michigan Cancer Center, Ann Arbor,  Michigan,  48109,  United States; Recruiting

Study ID Numbers:  FD-R-2021-01; FD-R-002021-01
Record last reviewed:  January 2002
Record first received:  February 26, 2002
ClinicalTrials.gov Identifier:  NCT00031148
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09