Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
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|ClinicalTrials.gov Identifier: NCT00070616|
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : October 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Myeloma||Drug: Palifermin 6 x 60 μg/kg/day Drug: Palifermin 2 x 180 μg/kg/day Radiation: radiotherapy Drug: Chemotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
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
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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070616