Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Background:

      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.

      Objectives:

      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.

      Eligibility:

      Patients with cytologically or histologically confirmed progressive, recurrent, or refractory
      stage IIIb or IV NSCLC.

      Patients must be HLA-A2 positive.

      Design:

      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.
    

Intervention name(s): Talactoferrin; Apheresis
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Talactoferrin alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung Cancer; Immunity; Clinical Response; Cytokines; Elispot Assay; Non-Small Cell Lung Cancer; NSCLC