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

Sponsor

CuraGen Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00104065

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2005

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Research Facility	LaJolla	California	United States	92037
2	Research Facility	Denver	Colorado	United States	80218
3	Research Facility	Miami	Florida	United States	33136
4	Research Facility	Chicago	Illinois	United States	60611
5	Research Facility	Worcester	Massachusetts	United States	01655
6	Research Facility	New York	New York	United States	10021
7	Research Facility	Winston Salem	North Carolina	United States	27157
8	Research Facility	Cleveland	Ohio	United States	44195
9	Research Facility	Portland	Oregon	United States	97239