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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00610818
Other study ID # BMB-6-24
Secondary ID BMB-06-24
Status Terminated
Phase N/A
First received January 28, 2008
Last updated January 28, 2008
Start date July 2007
Est. completion date January 2008

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Palifermin
day -14, -13, -12 before transplant and then day 0,1,2 after transplant

Locations

Country Name City State
Canada McGill University Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

See also
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