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