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

March 14, 2016 updated by: CuraGen Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • LaJolla, California, United States, 92037
        • Research Facility
    • Colorado
      • Denver, Colorado, United States, 80218
        • Research Facility
    • Florida
      • Miami, Florida, United States, 33136
        • Research Facility
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Facility
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Research Facility
    • New York
      • New York, New York, United States, 10021
        • Research Facility
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Research Facility
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Facility
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CuraGen Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

February 22, 2005

First Submitted That Met QC Criteria

February 22, 2005

First Posted (ESTIMATE)

February 23, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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