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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323518
First Posted: May 9, 2006
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (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 ( CuraGen Corporation ):

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323518


  Show 33 Study Locations
Sponsors and Collaborators
CuraGen Corporation
  More Information

Responsible Party: CuraGen Corporation
ClinicalTrials.gov Identifier: NCT00323518     History of Changes
Other Study ID Numbers: CG53135-CLN-12
First Submitted: May 8, 2006
First Posted: May 9, 2006
Last Update Posted: April 13, 2016
Last Verified: March 2016

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

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