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

This study has been terminated.
(We did not see any effect of Palifermin on benign or malignant tumor growth)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610818
First Posted: February 8, 2008
Last Update Posted: February 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
  Purpose

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.


Condition Intervention
Skin Rash Other: Palifermin

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Enrollment: 7
Study Start Date: July 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Patients receiving palifermin to prevent mucositis from bone marrow transplant.
Other: Palifermin
day -14, -13, -12 before transplant and then day 0,1,2 after transplant
Other Name: keratinocyte growth factor

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients receiving palifermin for bone marrow transplantation.
Criteria

Inclusion Criteria: receiving bone marrow transplant -

Exclusion Criteria: not receiving other growth factors

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610818


Locations
Canada, Quebec
McGill University
Montreal, Quebec, Canada, h3a 1a1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: beatrice wang, MD McGill University
  More Information

Responsible Party: Dr. Beatrice Wang
ClinicalTrials.gov Identifier: NCT00610818     History of Changes
Other Study ID Numbers: BMB-6-24
BMB-06-24
First Submitted: January 28, 2008
First Posted: February 8, 2008
Last Update Posted: February 8, 2008
Last Verified: January 2008