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Brief Title: A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
Official Title: A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant
Study ID: NCT00323518
Brief Summary: CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center, Berkley, California, United States
Research Facility, La Jolla, California, United States
Scripps Green Medical Center, La Jolla, California, United States
University of Colorado Health Sciences Center, Aurora, Colorado, United States
Rocky Mountain Blood and Marrow Transplant Program, Denver, Colorado, United States
Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Louisiana State University Health Science Center, Shreveport, Louisiana, United States
Wayne State University, Detroit, Michigan, United States
MAYO Clinic, Rochester, Minnesota, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Biomedical Research Alliance of New York, Bronx, New York, United States
Cornell Medical Center, New York, New York, United States
Biomedical Research Alliance of New York, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Legacy Good Samaritan Hospital and Cancer Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase-Temple Bone Marrow Transplant Program, Philadelphia, Pennsylvania, United States
Roger Williams Medical Center, Providence, Rhode Island, United States
Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Health Science Center, San Antonio, Texas, United States
Medical College of Wisonsin, Milwaukee, Wisconsin, United States