Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
Summary
Background:
More effective therapies are needed for patients with non-small cell lung cancer (NSCLC)
whose disease has advanced or spread beyond the original site following standard treatment.
Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in
body secretions such as breast milk, tears and saliva.
In previous studies, talactoferrin improved life span in patients with NSCLC without causing
toxic side effects.
Objectives:
To examine the effects of talactoferrin on the immune system and determine its effectiveness
in treating NSCLC.
Eligibility:
Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse
following at least one course of treatment.
Design:
Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks,
followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on
the drug side effects and the response of the tumor.
Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital
signs and blood tests every 3 weeks.
CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6
weeks and 12 weeks and then every 12 weeks during the duration of treatment.
Apheresis: Quantities of white blood cells called lymphocytes are collected through a
procedure called apheresis in order to measure the immune response to treatment. In this
procedure, blood is collected through a needle placed in a vein in the arm (similar to
donating blood) and circulated through a cell separator machine. The lymphocytes are
extracted and the rest of the blood is returned to the body through the same needle.