Keratinocyte Growth Factor to Prevent Acute GVHD - Tabular View

Tracking Information
First Received Date ^ICMJE	February 26, 2002
Last Updated Date	January 31, 2006
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00031148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Keratinocyte Growth Factor to Prevent Acute GVHD
Official Title ^ICMJE	Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Graft-Vs-Host Disease
Intervention ^ICMJE	Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	72
Completion Date	August 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	3 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00031148
Responsible Party
Study ID Numbers ^ICMJE	FD-R-2021-01, FD-R-002021-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP