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

NCT00104065 | Completed Phase 2

• 1 other identifier: C-421
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

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.

Conditions

Stomatitis

Keywords

oral mucositis; oncology - supportive care; mouth diseases

Interventions

CG53135-05, velafermin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CuraGen Corporation: lead

Study Sites (9)

Research Facility

La Jolla, California, 92037, United States

Location

Research Facility

Denver, Colorado, 80218, United States

Location

Research Facility

Miami, Florida, 33136, United States

Location

Research Facility

Chicago, Illinois, 60611, United States

Location

Research Facility

Worcester, Massachusetts, 01655, United States

Location

Research Facility

New York, New York, 10021, United States

Location

Research Facility

Winston-Salem, North Carolina, 27157, United States

Location

Research Facility

Cleveland, Ohio, 44195, United States

Location

Research Facility

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Stomatitis; Mouth Diseases

Interventions

FGF20 protein, human

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2005
• First Posted: February 23, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 15, 2016

Record last verified: 2016-02

Locations

US (9)