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

NCT00610818 | Terminated

• 2 other identifiers: BMB-6-24BMB-06-24
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Rash

Study Arms (1)

A

Patients receiving palifermin to prevent mucositis from bone marrow transplant.

Other: Palifermin

Interventions

Palifermin OTHER

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

Also known as: keratinocyte growth factor

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients receiving palifermin for bone marrow transplantation.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University

Montreal, Quebec, h3a 1a1, Canada

Location

MeSH Terms

Conditions

Exanthema

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• beatrice wang, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: July 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 8, 2008

Record last verified: 2008-01

Locations

CA (1)