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

Phase 2

Completed

• Conditions: Stomatitis; Oral Mucositis
• Interventions: Drug: placebo; Drug: velafermin

• Registration Number: NCT00323518
• Lead Sponsor: CuraGen Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-09
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Disposition First Submitted: 2015-02-02
• Disposition First Submitted QC: 2016-02-16
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Disposition First Posted: 2016-03-15
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	placebo
3	velafermin	10 mcg/kg velafermin
4	velafermin	60 mcg/kg velafermin
2	velafermin	30 mcg/kg velafermin

Primary Outcome Measures

Name	Time	Method
the incidence of grade 3/4 oral mucositis using WHO grading system	evaluated throughout the study

Trial Locations

Locations (32)

Alta Bates Comprehensive Cancer Center; 🇺🇸 Berkley, California, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Research Facility; 🇺🇸 La Jolla, California, United States

Scripps Green Medical Center; 🇺🇸 La Jolla, California, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Rocky Mountain Blood and Marrow Transplant Program; 🇺🇸 Denver, Colorado, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

St. Francis Hospital and Health Centers; 🇺🇸 Beech Grove, Indiana, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

MAYO Clinic; 🇺🇸 Rochester, Minnesota, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Biomedical Research Alliance of New York; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Cornell Medical Center; 🇺🇸 New York, New York, United States

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Legacy Good Samaritan Hospital and Cancer Center; 🇺🇸 Portland, Oregon, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Fox Chase-Temple Bone Marrow Transplant Program; 🇺🇸 Philadelphia, Pennsylvania, United States

Roger Williams Medical Center; 🇺🇸 Providence, Rhode Island, United States

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Medical University of South Carolina Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States

Medical College of Wisonsin; 🇺🇸 Milwaukee, Wisconsin, United States

Louisiana State University Health Science Center; 🇺🇸 Shreveport, Louisiana, United States

Cancer Center at Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States