Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
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.
To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC.
Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment.
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.
Non-Small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Pilot Study to Evaluate the Effect on the Immune System of Talactoferrin in Adults With Non-Small Cell Lung Cancer (NSCLC)|
- To evaluate the effects of talactoferrin to patients with advanced NSCLC on quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in s...
- To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
|Study Start Date:||June 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Patients with locally advanced or metastatic NSCLC have a very poor prognosis even with surgery, chemotherapy, and radiation treatments.
Patients who respond to 1st line chemotherapy invariably develop disease progression, and their median survival is between 6-8 months.
Talactoferrin alfa (TLF) is a recombinant human lactoferrin.
TLF displays anti-infective (against bacteria, viruses, protozoa and fungi) and anti-inflammatory properties, anti-tumor activity and anti-asthma properties.
Preclinical studies have demonstrated an increase in cytokines that stimulate both innate and adaptive immunity, as well as increasing the numbers of NK-T cells and CD8+ T-lymphocytes found in Peyer s Patches.
Previous studies in NSCLC have demonstrated safety and evidence of clinical activity.
Primary: To evaluate the effects of administration of talactoferrin to patients with advanced non-small cell lung cancer on the quantitative and functional changes in CD4, CD8, NK, and Treg populations in peripheral blood mononuclear cells (PBMC) and on the levels of cytokines and chemokines in serum.
Secondary: To evaluate clinical response to talactoferrin. To evaluate the safety of talactoferrin.
Patients with cytologically or histologically confirmed progressive, recurrent, or refractory stage IIIb or IV NSCLC.
Patients must be HLA-A2 positive.
Single-arm pilot study
Ten patients will be enrolled to receive daily oral talactoferrin (1.5 g/ bid) for up to 12 weeks.
Patients who benefit from treatment will be able to continue on a 12 weeks on 2 weeks off schedule until progression.
Evaluation will be performed every 3 weeks with CT chest, abdomen, and pelvis at baseline, week 6, and week 12.
Immunologic studies (including apheresis) will be performed at baseline, week 6, and week 12.
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||James L Gulley, M.D.||National Cancer Institute (NCI)|