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

March 14, 2016 updated by: CuraGen Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
390

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Berkley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • La Jolla, California, United States, 92037
        • Research Facility
      • La Jolla, California, United States, 92037
        • Scripps Green Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Sciences Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Blood and Marrow Transplant Program
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital and Health Centers
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • Louisiana State University Health Science Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Cancer Center at Hackensack University Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Biomedical Research Alliance Of New York
      • New York, New York, United States, 10021
        • Cornell Medical Center
      • New York, New York, United States, 10029
        • Biomedical Research Alliance Of New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97227
        • Legacy Good Samaritan Hospital and Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase-Temple Bone Marrow Transplant Program
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hollings Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisonsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the incidence of grade 3/4 oral mucositis using WHO grading system
Time Frame: evaluated throughout the study
evaluated throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CuraGen Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CG53135-CLN-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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