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

This study has been completed.

First Received: February 22, 2005 Last Updated: May 6, 2008 History of Changes

Sponsored by:	CuraGen Corporation
Information provided by:	CuraGen Corporation
ClinicalTrials.gov Identifier:	NCT00104065

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 II

MedlinePlus related topics: Mouth Disorders

Drug Information available for: Velafermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Keywords provided by CuraGen Corporation:

oral mucositis
oncology - supportive care
mouth diseases

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Mouth Diseases
Digestive System Diseases
Mucositis
Stomatitis

Gastrointestinal Diseases
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009