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

This study has been completed.

Sponsor:

Information provided by:

CuraGen Corporation

ClinicalTrials.gov Identifier:

NCT00104065

First received: February 22, 2005

Last updated: May 6, 2008

Last verified: May 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2005
Last Updated Date	May 6, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00104065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
Official Title ^ICMJE	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
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Stomatitis
Intervention ^ICMJE	Drug: CG53135-05, velafermin
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104065
Other Study ID Numbers ^ICMJE	C-421
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	CuraGen Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	CuraGen Corporation
Verification Date	May 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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