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

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.