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

This study has been terminated.
(We did not see any effect of Palifermin on benign or malignant tumor growth)
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00610818
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Principal Investigator: beatrice wanG, md McGill University
  More Information

No publications provided

Responsible Party: Dr. Beatrice Wang
ClinicalTrials.gov Identifier: NCT00610818     History of Changes
Other Study ID Numbers: BMB-6-24, BMB-06-24
Study First Received: January 28, 2008
Last Updated: January 28, 2008
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 24, 2014