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

Sponsored by:	Amgen
Information provided by:	Amgen
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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Palifermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Further study details as provided by Amgen:

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

Amgen

Investigators

Study Director:

MD

Amgen

More Information

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications of Results:

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:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010182
Study First Received:	October 6, 2003
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00070616
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

mucositis
chemotherapy
radiation therapy

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Immunoproliferative Disorders
Multiple myeloma
Mucositis

Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009