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

Stomatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104065
• Other study ID #: C-421
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2005
• Last updated: March 14, 2016
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: February 2016
• Source: Celldex Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00124592

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Intervention

Drug:
• CG53135-05, velafermin

Locations

Country	Name	City	State
United States	Research Facility	Chicago	Illinois
United States	Research Facility	Cleveland	Ohio
United States	Research Facility	Denver	Colorado
United States	Research Facility	LaJolla	California
United States	Research Facility	Miami	Florida
United States	Research Facility	New York	New York
United States	Research Facility	Portland	Oregon
United States	Research Facility	Winston Salem	North Carolina
United States	Research Facility	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CuraGen Corporation

Country where clinical trial is conducted

United States,