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)
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00610818
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 28, 2008
January 28, 2008
July 2007
January 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation
Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients receiving palifermin for bone marrow transplantation.

Skin Rash
Other: Palifermin
day -14, -13, -12 before transplant and then day 0,1,2 after transplant
Other Name: keratinocyte growth factor
A
Patients receiving palifermin to prevent mucositis from bone marrow transplant.
Intervention: Other: Palifermin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria: receiving bone marrow transplant -

Exclusion Criteria: not receiving other growth factors

-

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00610818
BMB-6-24, BMB-06-24
No
Dr. Beatrice Wang
McGill University Health Center
Not Provided
Principal Investigator: beatrice wang, MD McGill University
Principal Investigator: beatrice wanG, md McGill University
McGill University Health Center
January 2008

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