Status:
COMPLETED
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
Lead Sponsor:
CuraGen Corporation
Conditions:
Stomatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00104065
Start Date
January 1 2005
End Date
December 1 2005
Last Update
March 15 2016
Active Locations (9)
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1
Research Facility
La Jolla, 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