Skin Rash Clinical Trial
— PaliferminOfficial title:
Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation
Verified date | January 2008 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: receiving bone marrow transplant - Exclusion Criteria: not receiving other growth factors |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | McGill University | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
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