Clinical trial NCT00323518: A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Stomatitis
Keywords: oral mucositis
hematologic
autologous stem cell transplant
velafermin
stomatitis
oncology - supportive care
mouth diseases
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: the incidence of grade 3/4 oral mucositis using WHO grading system
timeFrame: evaluated throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Berkley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: La Jolla
country: United States
facility: Research Facility
state: California
city: La Jolla
country: United States
facility: Scripps Green Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Blood and Marrow Transplant Program
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Beech Grove
country: United States
facility: St. Francis Hospital and Health Centers
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Rochester
country: United States
facility: MAYO Clinic
state: Minnesota
city: Hackensack
country: United States
facility: Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: New York
country: United States
facility: Cornell Medical Center
state: New York
city: New York
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Legacy Good Samaritan Hospital and Cancer Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase-Temple Bone Marrow Transplant Program
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina Hollings Cancer Center
state: South Carolina
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisonsin
state: Wisconsin
Study officials:
References: