Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

This study has been completed.

First Received on October 6, 2003. Last Updated on February 27, 2009 History of Changes

Sponsor:	Swedish Orphan Biovitrum
Information provided by:	Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:	NCT00070616

Purpose

Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.

Condition	Intervention	Phase
Leukemia Lymphoma Myeloma	Drug: Palifermin	Phase I

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Lymphoma

Drug Information available for: Palifermin

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:

To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation

Secondary Outcome Measures:

To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.
To assess oral mucositis in subjects receiving rHuKGF.

Study Start Date:

December 2001

Detailed Description:

Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. Currently, no standard therapy is available to prevent or treat mucositis.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma. - Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070616

Sponsors and Collaborators

Swedish Orphan Biovitrum

Investigators

Study Director:

Amgen

More Information

Additional Information:

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

Zia-Amirhosseini P, Hurd DD, Salfi M, Cheah TC, Aycock J, Cesano A. Pharmacokinetics of palifermin administered as the standard dose and as a collapsed dose in patients with hematologic malignancies. Pharmacotherapy. 2007 Oct;27(10):1353-60.

Responsible Party:	Clinical Development, Biovitrum Ab (publ)
ClinicalTrials.gov Identifier:	NCT00070616 History of Changes
Obsolete Identifiers:	NCT00963170
Other Study ID Numbers:	20010182
Study First Received:	October 6, 2003
Last Updated:	February 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Swedish Orphan Biovitrum:

mucositis
chemotherapy
radiation therapy

Additional relevant MeSH terms:

Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 13, 2012