Status:
COMPLETED
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
Lead Sponsor:
CuraGen Corporation
Conditions:
Oral Mucositis
Stomatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ef...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00323518
Start Date
May 1 2006
End Date
August 1 2008
Last Update
April 13 2016
Active Locations (33)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Alta Bates Comprehensive Cancer Center
Berkley, California, United States, 94704
3
Research Facility
La Jolla, California, United States, 92037
4
Scripps Green Medical Center
La Jolla, California, United States, 92037