Clinical trial NCT00104065: Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomatitis
Keywords: oral mucositis
oncology - supportive care
mouth diseases
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-02-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: Research Facility
state: California
city: Denver
country: United States
facility: Research Facility
state: Colorado
city: Miami
country: United States
facility: Research Facility
state: Florida
city: Chicago
country: United States
facility: Research Facility
state: Illinois
city: Worcester
country: United States
facility: Research Facility
state: Massachusetts
city: New York
country: United States
facility: Research Facility
state: New York
city: Winston Salem
country: United States
facility: Research Facility
state: North Carolina
city: Cleveland
country: United States
facility: Research Facility
state: Ohio
city: Portland
country: United States
facility: Research Facility
state: Oregon
Study officials:
References: