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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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CG53135-05, velafermin

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No