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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00104065
Recruitment Status : Completed
First Posted : February 23, 2005
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics ( CuraGen Corporation )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Stomatitis Drug: CG53135-05, velafermin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Velafermin

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104065


Locations
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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
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Responsible Party: CuraGen Corporation
ClinicalTrials.gov Identifier: NCT00104065    
Obsolete Identifiers: NCT00124592
Other Study ID Numbers: C-421
First Posted: February 23, 2005    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: February 2016
Keywords provided by Celldex Therapeutics ( CuraGen Corporation ):
oral mucositis
oncology - supportive care
mouth diseases
Additional relevant MeSH terms:
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Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases