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

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ClinicalTrials.gov Identifier: NCT00104065

Recruitment Status : Completed

First Posted : February 23, 2005

Last Update Posted : March 15, 2016

Sponsor:

Information provided by (Responsible Party):

Celldex Therapeutics ( CuraGen Corporation )

Tracking Information

First Submitted Date ^ICMJE

February 22, 2005

First Posted Date ^ICMJE

February 23, 2005

Last Update Posted Date

March 15, 2016

Study Start Date ^ICMJE

January 2005

Actual Primary Completion Date

December 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention

Condition ^ICMJE

Stomatitis

Intervention ^ICMJE

Drug: CG53135-05, velafermin

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* 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

Not Provided

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

December 2005

Actual Primary Completion Date

December 2005 (Final data collection date for primary outcome measure)

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)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00104065

Other Study ID Numbers ^ICMJE

C-421

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Celldex Therapeutics ( CuraGen Corporation )

Study Sponsor ^ICMJE

CuraGen Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Celldex Therapeutics

Verification Date

February 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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