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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.
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation ) Identifier:
First received: February 22, 2005
Last updated: March 14, 2016
Last verified: February 2016
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
Drug: CG53135-05, velafermin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Celldex Therapeutics:

Study Start Date: January 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00104065

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

Responsible Party: CuraGen Corporation Identifier: NCT00104065     History of Changes
Obsolete Identifiers: NCT00124592
Other Study ID Numbers: C-421
Study First Received: February 22, 2005
Last Updated: March 14, 2016

Keywords provided by Celldex Therapeutics:
oral mucositis
oncology - supportive care
mouth diseases

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on March 28, 2017