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Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation

This study has been terminated.
( We did not see any effect of Palifermin on benign or malignant tumor growth )

Sponsored by: McGill University Health Center
Information provided by: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00610818
  Purpose

We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.

Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.


Condition Intervention
Skin Rash
Other: Palifermin

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Rashes    Skin Cancer   

ChemIDplus related topics:   Palifermin    Fibroblast growth factor 7   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation

Further study details as provided by McGill University Health Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   7
Study Start Date:   July 2007
Study Completion Date:   January 2008
Primary Completion Date:   January 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
A
Patients receiving palifermin to prevent mucositis from bone marrow transplant.
Other: Palifermin
day -14, -13, -12 before transplant and then day 0,1,2 after transplant

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

patients receiving palifermin for bone marrow transplantation.


Criteria

Inclusion Criteria: receiving bone marrow transplant -

Exclusion Criteria: not receiving other growth factors

-

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610818

Locations
Canada, Quebec
Mcgill University    
      montreal, Quebec, Canada, h3a 1a1

Sponsors and Collaborators
McGill University Health Center

Investigators
Principal Investigator:     beatrice wang, MD     McGill University    
Principal Investigator:     beatrice wanG, md     McGill University    
  More Information

Responsible Party:   ( Dr. Beatrice Wang )
Study ID Numbers:   BMB-6-24, BMB-06-24
First Received:   January 28, 2008
Last Updated:   January 28, 2008
ClinicalTrials.gov Identifier:   NCT00610818
Health Authority:   Canada: Ethics Review Committee

Study placed in the following topic categories:
Exanthema
Skin Diseases
Skin Neoplasms

ClinicalTrials.gov processed this record on August 29, 2008




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