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NCT Number: NCT00104065

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

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Key information

Conditions

Stomatitis Mouth Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Facility, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CG53135-05, velafermin

Drug

Sponsors and collaborators

Lead sponsor

CuraGen Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Feb 23, 2005
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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