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

This study has been completed.
Sponsor:
Information provided by:
CuraGen Corporation
ClinicalTrials.gov Identifier:
NCT00323518
First received: May 8, 2006
Last updated: January 14, 2009
Last verified: January 2009
History of Changes
  Purpose

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
Stomatitis
 Drug: velafermin
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Velafermin
U.S. FDA Resources

Further study details as provided by CuraGen Corporation:

Primary Outcome Measures:
  • the incidence of grade 3/4 oral mucositis using WHO grading system [ Time Frame: evaluated throughout the study ] [ Designated as safety issue: No ]

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
placebo
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323518

  Show 33 Study Locations
Sponsors and Collaborators
CuraGen Corporation
  More Information

No publications provided

Responsible Party: Vice President, Regulatory Affairs and Quality Assurance, CuraGen Corporation
ClinicalTrials.gov Identifier: NCT00323518     History of Changes
Other Study ID Numbers: CG53135-CLN-12
Study First Received: May 8, 2006
Last Updated: January 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by CuraGen Corporation:
oral mucositis
hematologic
autologous stem cell transplant
velafermin
 stomatitis
oncology - supportive care
mouth diseases

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013