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



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2006
End Date:August 2008

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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

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.


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.
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201 Dowman Dr
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529 West Markham Street
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New York, New York 10021
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3181 Southwest Sam Jackson Park Road
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Beech Grove, Indiana 46107
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Chapel Hill, North Carolina 27599
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1653 W. Congress Parkway
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303 East Superior Street
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11100 Euclid Ave
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2301 Erwin Rd
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Indianapolis, Indiana 46202
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200 Hawkins Dr,
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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La Jolla, California 92037
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Milwaukee, Wisconsin 53226
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1100 N. Lindsay
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Philadelphia, Pennsylvania 19111
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Rochester, Minnesota 55905
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
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