Vaccine Therapy Before Surgery in Treating Patients With Localized Kidney Cancer

PRIMARY OBJECTIVES:

I. To assess the immune-modulatory systemic and intratumoral effects of AGS-003 (renal cell
carcinoma/cluster of differentiation [CD]40L ribonucleic acid [RNA]-transfected autologous
dendritic cell vaccine AGS-003) as neoadjuvant treatment in patients with localized renal
cell carcinoma.

SECONDARY OBJECTIVES:

I. To assess the feasibility that total tumor RNA processing-related activities meet
specifications for AGS-003 manufacturing utilizing a core needle biopsy procedure for tumor
harvesting prior to nephrectomy.

OUTLINE:

Patients receive 3 injections of renal cell carcinoma/cluster of CD40L RNA-transfected
autologous dendritic cell vaccine AGS-003 intradermally (ID) once every 7 days during weeks
6-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo
partial or radical nephrectomy on week 10.

After completion of study treatment, patients are followed up at 1 month.

Inclusion Criteria:

- Have localized non-metastatic renal cell carcinoma (RCC) (< pT2, NO, MO), as per the
American Joint Committee on Cancer (AJCC) seventh (7th) edition criteria

- Must be surgical candidates as deemed fit by surgeon

- Patients of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform the treating physician immediately

- Willingness to undergo leukapheresis and biopsy procedures for the autologous
components (peripheral blood mononuclear cells, plasma and fresh tumor specimen)
required for manufacture of AGS-003

- Patient or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (e.g., shortness of breath, fatigue,
orthopnea, paroxysmal nocturnal dyspnea), unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Radiation to primary tumor prior to enrollment in this study

- Pregnant or nursing female patients

- Unwilling or unable to follow protocol requirements

- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
(e.g., rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ
transplant recipient, etc.)

- NOTE: abnormal laboratory values for autoimmunity markers in the absence of other
signs/symptoms of autoimmune disease are not exclusionary

- Known clinically significant infections, including human immunodeficiency virus (HIV)
and active hepatitis B or C

- Any condition which in the Investigator's opinion deems the patient an unsuitable
candidate to receive treatment (i.e., any significant medical illness or abnormal
laboratory finding that would, in the investigator's judgment, increase the subject's
risk by participating in this study)

- Chronic use of systemic corticosteroids (i.e., >= 10 mg/day prednisone or equivalent)

- Received an investigational agent within 30 days prior to enrollment