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Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

This study has been completed.
Sponsor:
Information provided by:
CuraGen Corporation
ClinicalTrials.gov Identifier:
NCT00104065
First received: February 22, 2005
Last updated: May 6, 2008
Last verified: May 2008
History of Changes
  Purpose

CG53135-05, 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 evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.


Condition Intervention Phase
Stomatitis
 Drug: CG53135-05, velafermin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant

Resource links provided by NLM:

MedlinePlus related topics: Mouth Disorders
Drug Information available for: Velafermin
U.S. FDA Resources

Further study details as provided by CuraGen Corporation:

Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ages > 18 yrs
  • Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
  • Patients with Karnofsky performance scores > or = 70%
  • Informed consent for participation in study

Exclusion Criteria:

  • Patients who weigh < 33 kg
  • Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
  • Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
  • Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
  • Patients with known hypersensitivity to recombinant protein therapeutics
  • Patients who have taken CG53135-05, palifermin or 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 oral mucositis (OM)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104065

Locations
United States, California
Research Facility
LaJolla, California, United States, 92037
United States, Colorado
Research Facility
Denver, Colorado, United States, 80218
United States, Florida
Research Facility
Miami, Florida, United States, 33136
United States, Illinois
Research Facility
Chicago, Illinois, United States, 60611
United States, Massachusetts
Research Facility
Worcester, Massachusetts, United States, 01655
United States, New York
Research Facility
New York, New York, United States, 10021
United States, North Carolina
Research Facility
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Research Facility
Cleveland, Ohio, United States, 44195
United States, Oregon
Research Facility
Portland, Oregon, United States, 97239
Sponsors and Collaborators
CuraGen Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104065     History of Changes
Obsolete Identifiers: NCT00124592
Other Study ID Numbers: C-421
Study First Received: February 22, 2005
Last Updated: May 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by CuraGen Corporation:
oral mucositis
oncology - supportive care
mouth diseases

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013