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A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00323518•CuraGen Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

Locations (33)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Comprehensive Cancer Center

Berkley, California, 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

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St. Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Key Dates

Start Date

May 1, 2006

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

April 13, 2016

Enrollment

390

ACTUAL participants

Conditions

Oral MucositisStomatitis

Interventions

velafermin

DRUG

placebo

DRUG

Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692

Oral Mucositis

View study

RECRUITINGPHASE2

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

NCT07040969

Radiation-induced Oral Mucositis

View study

RECRUITING

Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis

NCT06968520

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prevention of Oral Mucositis in Head and Neck Cancer.

Spirulina-Derived Product Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis

Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

Benzydamine for Radiation-Induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy

Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome