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

Sobi

Status and phase: Completed; Phase 1

Conditions: Lymphoma; Myeloma; Leukemia

Treatments: Drug: Chemotherapy; Radiation: radiotherapy; Drug: Palifermin 2 x 180 μg/kg/day; Drug: Palifermin 6 x 60 μg/kg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT00070616

20010182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Palifermin 6 x 60 μg/kg/day

Experimental group

Description:

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).

Treatment:

Drug: Chemotherapy

Radiation: radiotherapy

Drug: Palifermin 6 x 60 μg/kg/day

Palifermin 2 x 180 μg/kg/day

Experimental group

Description:

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

Treatment:

Drug: Chemotherapy

Radiation: radiotherapy

Drug: Palifermin 2 x 180 μg/kg/day