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

Tracking Information

First Received Date ^ICMJE

October 6, 2003

Last Updated Date

February 27, 2009

Start Date ^ICMJE

December 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00070616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Lymphoma
Myeloma

Intervention ^ICMJE

Drug: Palifermin

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 76 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00070616

Responsible Party

Clinical Development, Biovitrum Ab (publ)

Study ID Numbers ^ICMJE

20010182

Study Sponsor ^ICMJE

Biovitrum

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Biovitrum

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP