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