A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
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
1 other identifier
interventional
390
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedApril 13, 2016
March 1, 2016
2.3 years
May 8, 2006
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of grade 3/4 oral mucositis using WHO grading system
evaluated throughout the study
Study Arms (4)
1
PLACEBO COMPARATORplacebo
2
EXPERIMENTAL30 mcg/kg velafermin
3
EXPERIMENTAL10 mcg/kg velafermin
4
EXPERIMENTAL60 mcg/kg velafermin
Interventions
administered intravenously as 100mL single dose over 15 minutes on day 1
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Alta Bates Comprehensive Cancer Center
Berkley, California, 94704, United States
Research Facility
La Jolla, California, 92037, United States
Scripps Green Medical Center
La Jolla, California, 92037, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Louisiana State University Health Science Center
Shreveport, Louisiana, 71130, United States
Wayne State University
Detroit, Michigan, 48201, United States
MAYO Clinic
Rochester, Minnesota, 55905, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cornell Medical Center
New York, New York, 10021, United States
Biomedical Research Alliance of New York
New York, New York, 10029, United States
Biomedical Research Alliance of New York
The Bronx, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Legacy Good Samaritan Hospital and Cancer Center
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Fox Chase-Temple Bone Marrow Transplant Program
Philadelphia, Pennsylvania, 19111, United States
Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Health Science Center
San Antonio, Texas, 78229-3900, United States
Medical College of Wisonsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 9, 2006
Study Start
May 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
April 13, 2016
Record last verified: 2016-03