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

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.
 
ClinicalTrials.gov Identifier: NCT00323518
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation )

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 9, 2006
Last Update Posted Date April 13, 2016
Study Start Date  ICMJE May 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
the incidence of grade 3/4 oral mucositis using WHO grading system [ Time Frame: evaluated throughout the study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Oral Mucositis
  • Stomatitis
Intervention  ICMJE
  • Drug: velafermin
    administered intravenously as 100mL single dose over 15 minutes on day 1
    Other Name: CG53135-05
  • Drug: placebo
    administered intravenously as 100mL single dose over 15 minutes on day 1
Study Arms  ICMJE
  • Placebo Comparator: 1
    placebo
    Intervention: Drug: placebo
  • Experimental: 2
    30 mcg/kg velafermin
    Intervention: Drug: velafermin
  • Experimental: 3
    10 mcg/kg velafermin
    Intervention: Drug: velafermin
  • Experimental: 4
    60 mcg/kg velafermin
    Intervention: Drug: velafermin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2007)
390
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00323518
Other Study ID Numbers  ICMJE CG53135-CLN-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celldex Therapeutics ( CuraGen Corporation )
Study Sponsor  ICMJE CuraGen Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Celldex Therapeutics
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP