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

Exclusion Criteria

• •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