Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma

Inclusion Criteria: * Age ≥18 years * Histologically confirmed, advanced or metastatic RCC with predominantly clear cell histology that is unresectable or medically inoperable. * Experienced and failed at least one regimen of systemic therapy for RCC with CT documentation of disease progression. * A previous CT (4 weeks or more prior to the Screening CT) showing progression of the target tumor(s) compared to a prior CT no more than 9 months previously * At least one target tumor lesion is measurable at Screening with CT scan, according to RECIST, and not previously irradiated * Karnofsky performance status of ≥70 (ECOG \<2) * Able to understand and sign an informed consent Exclusion Criteria: * Significant sarcomatoid, spindle cell, or nuclear grade 4 histology * Significant non-clear cell RCC (for example, papillary, chromophobe, collecting duct, granular, or unclassified RCC) * Total bilirubin \>1.5 mg/dL * Serum creatinine \>2.0 mg/dL * Hemoglobin \<10.0 g/dL * Absolute neutrophil count \<2000/mm3 * Lymphocytes \<800/mm3 * Platelet count \<100,000/mm3 * AST (SGOT) or ALT (SGPT) ≥2.5 x institutional upper limit of normal * Serum calcium \>11.5 mg/dl * International Normalized Ratio of Prothrombin Time (INR) \>1.2 * FEV1 \<60% predicted or FVC \<60% predicted by spirometry (both are to be measured) * Existing or history of brain metastases * History of allergic reactions to compounds of similar chemical or biologic composition to the Study Agent rhLF * Active ischemic heart disease, symptomatic congestive heart failure * Serious active infection * Psychiatric illness/social situations that would limit compliance with study requirements * Autoimmune diseases (e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis) * Other malignancies, except non-melanoma skin cancer, within 5 years of study entry * Radiotherapy within 4 weeks prior to study treatment start * Corticosteroid therapy within 4 weeks prior to treatment start, with the exception of inhaled or topical steroids * Chemotherapy/Immunotherapy (e.g., IL-2, INFα, tumor vaccine) within 4 weeks prior to study treatment start * Known HIV positive * Receipt of any investigational medication within 30 days prior to participation in the study * Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum β-human chorionic gonadotropin \[β-HCG\] at Screening and on Day 1 prior to the first dose), or fertile female patients unwilling to use adequate contraception prior to study entry, during treatment and 30 days after completion of treatment * Sexually active male patients unwilling to practice contraception while participating on this study and up to 30 days after completion of treatment * Unable to take liquid medication by mouth or feeding tube