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

Sponsor

CuraGen Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00323518

Collaborator

(none)

390

Enrollment

Locations

Arms

Duration (Months)

11.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis Stomatitis	Drug: velafermin Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

May 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 placebo	Drug: placebo administered intravenously as 100mL single dose over 15 minutes on day 1
Experimental: 2 30 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1 Other Names: CG53135-05
Experimental: 3 10 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1 Other Names: CG53135-05
Experimental: 4 60 mcg/kg velafermin	Drug: velafermin administered intravenously as 100mL single dose over 15 minutes on day 1 Other Names: CG53135-05

Outcome Measures

Primary Outcome Measures

the incidence of grade 3/4 oral mucositis using WHO grading system [evaluated throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045
6	Rocky Mountain Blood and Marrow Transplant Program	Denver	Colorado	United States	80218
7	Emory University	Atlanta	Georgia	United States	30322
8	Northwestern University	Chicago	Illinois	United States	60611
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	St. Francis Hospital and Health Centers	Beech Grove	Indiana	United States	46107
11	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202
12	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
13	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
14	Louisiana State University Health Science Center	Shreveport	Louisiana	United States	71130
15	Wayne State University	Detroit	Michigan	United States	48201
16	MAYO Clinic	Rochester	Minnesota	United States	55905
17	Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
18	Biomedical Research Alliance of New York	Bronx	New York	United States	10467
19	Cornell Medical Center	New York	New York	United States	10021
20	Biomedical Research Alliance of New York	New York	New York	United States	10029
21	University of North Carolina	Chapel Hill	North Carolina	United States	27599
22	Duke University Medical Center	Durham	North Carolina	United States	27710
23	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
24	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
25	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
26	Legacy Good Samaritan Hospital and Cancer Center	Portland	Oregon	United States	97227
27	Oregon Health and Science University	Portland	Oregon	United States	97239
28	Fox Chase-Temple Bone Marrow Transplant Program	Philadelphia	Pennsylvania	United States	19111
29	Roger Williams Medical Center	Providence	Rhode Island	United States	02908
30	Medical University of South Carolina Hollings Cancer Center	Charleston	South Carolina	United States	29425
31	Baylor University Medical Center	Dallas	Texas	United States	75246
32	University of Texas Health Science Center	San Antonio	Texas	United States	78229-3900
33	Medical College of Wisonsin	Milwaukee	Wisconsin	United States	53226