Trial | NCT00070616  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    palifermin ...

  • Study Participants

    25
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.
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 Started
Dec 31
2001
Primary Completion
Mar 31
2005
Study Completion
Mar 31
2005
Last Update
Oct 24
2014
Estimate

Drug Palifermin 6 x 60 μg/kg/day

Drug Palifermin 2 x 180 μg/kg/day

Radiation radiotherapy

Drug Chemotherapy

Palifermin 6 x 60 μg/kg/day Experimental

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).

Palifermin 2 x 180 μg/kg/day Experimental

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

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.
No Results Posted