Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation|
|Study Start Date:||July 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Patients receiving palifermin to prevent mucositis from bone marrow transplant.
day -14, -13, -12 before transplant and then day 0,1,2 after transplant
Other Name: keratinocyte growth factor
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610818
|Montreal, Quebec, Canada, h3a 1a1|
|Principal Investigator:||beatrice wang, MD||McGill University|