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Spots Global Cancer Trial Database for A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

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Trial Identification

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

Interventions

velafermin
placebo

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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