A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis, Stomatitis

In brief

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.

Key facts

Study ID

NCT00323518

Run by

CuraGen Corporation

People needed

390

Starts

2006-05-01

Expected to finish

2008-08-01

Last updated by the study team

2016-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.
• Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
• ECOG Performance Score of 2 or less
• Signed Informed Consent Form (ICF)

You may not qualify if…

• Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
• Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
• Patients with known hypersensitivity to recombinant protein therapeutics
• Patients who have taken velafermin (CG53135-05) previously
• Patients who have taken palifermin in the past 90 days
• Patients who have taken other investigational drugs in the past 30 days
• Patients who have untreated symptomatic dental infection
• Patients with a history of sensitivity or allergy to E. coli-derived products
• Patients with WHO Grade 3 or 4 OM at the time of randomization
• Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
• Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
• Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.

Where it is running

• 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
• Cornell Medical Center — New York, New York, United States
• Biomedical Research Alliance of New York — New York, New York, United States
• Biomedical Research Alliance of New York — The Bronx, 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

Full record on ClinicalTrials.gov

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