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
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 |
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
CuraGen Corporation |
United States,
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