Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 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|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00070616