Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00923741

Run by

National Cancer Institute (NCI)

People needed

10

Starts

2008-06-19

Expected to finish

2010-02-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Presence of brain metastases, unless the patient received brain irradiation at least 4 weeks prior to enrollment, and is stable, asymptomatic, and off steroids for at least 4 weeks prior to registration
• History of allergic reactions to compounds of similar chemical or biologic composition to Talactoferrin. At this point, no specific compounds have been identified.
• History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for greater than or equal to 5 years
• Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure
• Serious active infection
• Psychiatric illness/ social situations that would limit study compliance
• Other uncontrolled serious chronic disease or conditions that in the investigator s opinion could render compliance or follow-up in the protocol problematic
• Concurrent radiotherapy or radiotherapy within 4 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
• Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted.
• HIV positive
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
• History of opportunistic infections
• Hepatitis B surface antigen positive or hepatitis C positive
• Receipt of any investigational medication within 4 weeks prior to enrollment.
• Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum beta-human chorionic gonadotropin [beta-hCG] at screening and at baseline), or fertile female patients unwilling to use adequate contraception (including condom use, birth control pills, or IUD) during treatment and 30 days after completion of treatment
• Sexually active male patients unwilling to practice contraception (condom use) while participating on the study and up to 30 days after completion of treatment
• Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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