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

This study has been completed.
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation ) Identifier:
First received: May 8, 2006
Last updated: March 14, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Oral Mucositis
Drug: velafermin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • the incidence of grade 3/4 oral mucositis using WHO grading system [ Time Frame: evaluated throughout the study ]

Enrollment: 390
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Drug: placebo
administered intravenously as 100mL single dose over 15 minutes on day 1
Experimental: 2
30 mcg/kg velafermin
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05
Experimental: 3
10 mcg/kg velafermin
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05
Experimental: 4
60 mcg/kg velafermin
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00323518

  Show 33 Study Locations
Sponsors and Collaborators
CuraGen Corporation
  More Information

Responsible Party: CuraGen Corporation Identifier: NCT00323518     History of Changes
Other Study ID Numbers: CG53135-CLN-12
Study First Received: May 8, 2006
Last Updated: March 14, 2016

Keywords provided by Celldex Therapeutics:
oral mucositis
autologous stem cell transplant
oncology - supportive care
mouth diseases

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on April 28, 2017