An Open Label Pilot Study to Evaluate the Effect on the Immune System of Talactoferrin in Adults With Non-Small Cell Lung Cancer (NSCLC)
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
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
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
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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...
Arun Rajan, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|