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

Phase 1

Completed

• Conditions: Lymphoma; Leukemia; Myeloma
• Interventions: Drug: Palifermin 2 x 180 μg/kg/day; Drug: Palifermin 6 x 60 μg/kg/day; Radiation: radiotherapy; Drug: Chemotherapy

• Registration Number: NCT00070616
• Lead Sponsor: Swedish Orphan Biovitrum

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 Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-10-06
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palifermin 2 x 180 μg/kg/day	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
Palifermin 6 x 60 μg/kg/day	radiotherapy	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 6 x 60 μg/kg/day	Chemotherapy	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 6 x 60 μg/kg/day	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).
Palifermin 2 x 180 μg/kg/day	radiotherapy	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
Palifermin 2 x 180 μg/kg/day	Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess oral mucositis in subjects receiving rHuKGF.
To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.