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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323518
• Other study ID #: CG53135-CLN-12
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2006
• Last updated: February 16, 2016
• Start date: May 2006
• Est. completion date: August 2008

Study information

• Verified date: February 2016
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
• placebo
administered intravenously as 100mL single dose over 15 minutes on day 1

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	St. Francis Hospital and Health Centers	Beech Grove	Indiana
United States	Alta Bates Comprehensive Cancer Center	Berkley	California
United States	Biomedical Research Alliance of New York	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Rocky Mountain Blood and Marrow Transplant Program	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Research Facility	La Jolla	California
United States	Scripps Green Medical Center	La Jolla	California
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Medical College of Wisonsin	Milwaukee	Wisconsin
United States	Biomedical Research Alliance of New York	New York	New York
United States	Cornell Medical Center	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Fox Chase-Temple Bone Marrow Transplant Program	Philadelphia	Pennsylvania
United States	Legacy Good Samaritan Hospital and Cancer Center	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	MAYO Clinic	Rochester	Minnesota
United States	University of Texas Health Science Center	San Antonio	Texas
United States	Louisiana State University Health Science Center	Shreveport	Louisiana
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CuraGen Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of grade 3/4 oral mucositis using WHO grading system		evaluated throughout the study	No