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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Oral Mucositis, Stomatitis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

the incidence of grade 3/4 oral mucositis using WHO grading system

Outcome Time Frame:

evaluated throughout the study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CG53135-CLN-12

NCT ID:

NCT00323518

Start Date:

May 2006

Completion Date:

August 2008

Related Keywords:

  • Oral Mucositis
  • Stomatitis
  • oral mucositis
  • hematologic
  • autologous stem cell transplant
  • velafermin
  • stomatitis
  • oncology - supportive care
  • mouth diseases
  • Stomatitis
  • Mucositis

Name

Location

Mayo ClinicRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University Hospitals of ClevelandCleveland, Ohio  44106
Rush University Medical CenterChicago, Illinois  60612-3824
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Baylor University Medical CenterDallas, Texas  75246
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
University of OklahomaOklahoma City, Oklahoma  73190
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
University of Colorado Health Sciences CenterDenver, Colorado  80262
Cornell Medical CenterNew York, New York  10021
Emory UniversityAtlanta, Georgia  30322
Wayne State UniversityDetroit, Michigan  48202
University of Texas Health Science CenterSan Antonio, Texas  78284
Oregon Health and Science UniversityPortland, Oregon  97201
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Biomedical Research Alliance of New YorkNew York, New York  10016
Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina  29425
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218
Research FacilityLa Jolla, California  92037
Scripps Green Medical CenterLa Jolla, California  92037
Legacy Good Samaritan Hospital and Cancer CenterPortland, Oregon  97227
Fox Chase-Temple Bone Marrow Transplant ProgramPhiladelphia, Pennsylvania  19111
Medical College of WisonsinMilwaukee, Wisconsin  53226