INCLUSION CRITERIA:
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed stage IIIB or IV NSCLC; confirmation of pathologic diagnosis to be conducted at the NCI Laboratory of Pathology
- Received at least one prior systemic anti-cancer therapy for advanced or metastatic NSCLC
- HLA-A2 allele
- Patient must have evaluable or measurable disease
- Total bilirubin less than or equal to 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0)
- Creatinine less than 1.5 times Upper Limit of Normal (ULN) if greater than 1.5 times ULN, creatinine clearance on a 24 hour urine collection of greater than 60 mL/min.
- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times the upper limit of normal (ULN); in case of liver metastases less than or equal to 5 x ULN
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Able to understand and give informed consent
- Recovered completely from any reversible toxicity associated with recent therapy. Typically this is 3-4 weeks for patients who most recently received cytotoxic therapy except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery.
- Hematological eligibility parameters (within 16 days of starting therapy):
- Granulocyte count greater than or equal to 1,500/mm(3)
- Platelet count greater than or equal to 75,000/mm(3)
- Hgb greater than or equal to 9 Gm/dL
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
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008