Oral MucositisPhase 2NCT00323518
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
A Phase 2 study testing velafermin in people with Oral Mucositis and Stomatitis, run by CuraGen Corporation at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Stomatitis
- What is being tested?
- velafermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 33 sitesUnited States
- Study dates
- May 2006to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Emory University
Atlanta, Georgia, 30322
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107
Alta Bates Comprehensive Cancer Center
Berkley, California, 94704
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Baylor University Medical Center
Dallas, Texas, 75246
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218
Wayne State University
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
Research Facility
La Jolla, California, 92037
Scripps Green Medical Center
La Jolla, California, 92037
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Medical College of Wisonsin
Milwaukee, Wisconsin, 53226
Cornell Medical Center
New York, New York, 10021
Biomedical Research Alliance of New York
New York, New York, 10029
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Fox Chase-Temple Bone Marrow Transplant Program
Philadelphia, Pennsylvania, 19111
Legacy Good Samaritan Hospital and Cancer Center
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
Roger Williams Medical Center
Providence, Rhode Island, 02908
MAYO Clinic
Rochester, Minnesota, 55905
University of Texas Health Science Center
San Antonio, Texas, 78229-3900
Louisiana State University Health Science Center
Shreveport, Louisiana, 71130
Biomedical Research Alliance of New York
The Bronx, New York, 10467
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
- Conditions
- Oral Mucositis, Stomatitis
- Being tested
- velafermin, placebo
- Keywords
- oral mucositis, hematologic, autologous stem cell transplant, velafermin, stomatitis, oncology - supportive care, mouth diseases
- Medical subject headings
- Stomatitis, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
velaferminDrug
Also called CG53135-05
administered intravenously as 100mL single dose over 15 minutes on day 1
placeboDrug
administered intravenously as 100mL single dose over 15 minutes on day 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo Receives: Drug: placebo |
| 2 | Experimental | 30 mcg/kg velafermin Receives: Drug: velafermin |
| 3 | Experimental | 10 mcg/kg velafermin Receives: Drug: velafermin |
| 4 | Experimental | 60 mcg/kg velafermin Receives: Drug: velafermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of grade 3/4 oral mucositis using WHO grading system
Measured: evaluated throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuraGen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323518
- Sponsor's protocol ID
- CG53135-CLN-12
- Status last verified
- Mar 2016
- First submitted
- 8 May 2006
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00323518
- Acronym / sponsor ID
- CG53135-CLN-12
- Conditions
- Oral Mucositis, Stomatitis
- Keywords
- oral mucositis, hematologic, autologous stem cell transplant, velafermin, stomatitis, oncology - supportive care, mouth diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- CuraGen CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo |
| 2 | Experimental | Drug: velafermin30 mcg/kg velafermin |
| 3 | Experimental | Drug: velafermin10 mcg/kg velafermin |
| 4 | Experimental | Drug: velafermin60 mcg/kg velafermin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| velaferminAlso: CG53135-05administered intravenously as 100mL single dose over 15 minutes on day 1 | Drug | 2, 3, 4 |
| placeboadministered intravenously as 100mL single dose over 15 minutes on day 1 | Drug | 1 |
Primary outcome
the incidence of grade 3/4 oral mucositis using WHO grading system
Time frame: evaluated throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing velafermin in people with Oral Mucositis and Stomatitis, run by CuraGen Corporation at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of grade 3/4 oral mucositis using WHO grading system (time frame: evaluated throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.