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

Completed · Phase 2

Conditions studied: Stomatitis

In brief

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.

Key facts

Study ID

NCT00104065

Run by

CuraGen Corporation

Starts

2005-01-01

Expected to finish

2005-12-01

Last updated by the study team

2016-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Research Facility — La Jolla, California, United States
• Research Facility — Denver, Colorado, United States
• Research Facility — Miami, Florida, United States
• Research Facility — Chicago, Illinois, United States
• Research Facility — Worcester, Massachusetts, United States
• Research Facility — New York, New York, United States
• Research Facility — Winston-Salem, North Carolina, United States
• Research Facility — Cleveland, Ohio, United States
• Research Facility — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.