Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
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.
Drug: Palifermin 6 x 60 μg/kg/day
Drug: Palifermin 2 x 180 μg/kg/day
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study of the Pharmacokinetics (PK) of Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF) in Subjects With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy Followed by Peripheral Blood Progenitor Cell (PBPC) Transplantation|
- 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
- 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|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Experimental: Palifermin 6 x 60 μg/kg/day
The first 3 consecutive daily doses were administered before the initiation of conditioning therapy (study days -11, -10, and -9); 3 additional consecutive daily doses were administered after administration of radiotherapy, chemotherapy and PBPC transplantation (study days 0, 1, and 2).
|Drug: Palifermin 6 x 60 μg/kg/day Radiation: radiotherapy Drug: Chemotherapy|
Experimental: Palifermin 2 x 180 μg/kg/day
The first dose was administered on study day -11, 3 days before the initiation of conditioning therapy, and the second dose was given on day 0 after administration of radiotherapy, chemotherapy and the PBPC infusion
|Drug: Palifermin 2 x 180 μg/kg/day Radiation: radiotherapy Drug: Chemotherapy|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070616