A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis - Full Text View

Sponsor:	CuraGen Corporation
Information provided by:	CuraGen Corporation
ClinicalTrials.gov Identifier:	NCT00323518

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Mouth Disorders

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
1: Placebo Comparator placebo	Drug: placebo administered intravenously as 100mL single dose over 15 minutes on day 1
2: Experimental 30 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1
3: Experimental 10 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1
4: Experimental 60 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1

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:	CuraGen Corporation ( Vice President, Regulatory Affairs and Quality Assurance )
Study ID Numbers:	CG53135-CLN-12
Study First Received:	May 8, 2006
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00323518 History of Changes
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:

Mouth Diseases
Digestive System Diseases
Mucositis
Stomatitis

Gastrointestinal Diseases
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010