A Phase IIa Study Testing the Biologic Activity and Safety of Autologous Renal Cell Carcinoma Total mRNA and huCD40L Newly Diagnosed Stage IV Renal Cell Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed clear cell renal cell carcinoma (RCC)

- Newly diagnosed disease

- Metastatic, stage IV disease (any T, any N, and M1)

- Confirmed diagnosis following nephrectomy on study OR has undergone nephrectomy for
RCC within the past 3 months AND meets the following criteria:

- Clear cell histology

- Metastatic lesion available for RNA isolation

- Stable disease not requiring any other antitumor treatment modality

- Prior nephrectomy following < stage IV disease with subsequent development of
metachronous metastasis allowed

- No requirement for bilateral nephrectomy for renal cancer

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- Bone metastases are not considered measurable disease

- No brain metastases by MRI

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Memorial Sloan Kettering Cancer Center risk group 0-1

- Body weight ≥ 30 kg

- Normal renal function in the contralateral kidney (kidney without tumor)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- WBC ≥ 4,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Absolute lymphocyte count ≥ 700/mm^3

- Hemoglobin ≥ 10 g/dL

- Transfusions for hemoglobin ≤ 10 g/dL allowed prior to or post-nephrectomy and
for up to 2 weeks prior to the first leukapheresis

- Creatinine < 1.5 mg/dL

- Total bilirubin < 2.0 mg/dL

- AST and ALT < 2 times upper limit of normal

- PT and PTT < 1.5 times control

- Corrected calcium < 10.5 mg/dL

- No cardiopulmonary disease

- No circulatory compromise

- No hepatic or renal dysfunction

- No uncontrolled hypertension

- No type I diabetes mellitus

- No active autoimmune disease including, but not limited to the following:

- Rheumatoid arthritis (RF-positive arthritis with current or recent flare)

- Inflammatory bowel disease

- Systemic lupus erythematosus (confirmed with anti-nuclear antibody ≥ 1:80)

- Ankylosing spondylitis

- Hashimoto's disease

- Scleroderma

- Multiple sclerosis

- Autoimmune hemolytic anemia

- Immune thrombocytopenic purpura

- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix or nonmelanoma skin cancer

- No active infections

- HIV negative

- No viral hepatitis

- No history of hypercalcemia or symptomatic hypercalcemia requiring management

- No known hypersensitivity to dimethyl sulfoxide

- No other serious medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 2 weeks since prior medications containing acetyl salicylic acid

- No prior therapy for renal cancer

- At least 2 months since prior and no concurrent chemotherapeutic agents

- At least 2 months since prior and no concurrent growth factors, cytokines, or white
lineage colony stimulating factors (e.g., filgrastim [G-CSF] and sargramostim
[GM-CSF])

- At least 2 months since prior and no concurrent immunosuppressive agents or
immunotherapy, including, but not limited to the following:

- Chronic topical corticosteroids (allowed to small areas of skin not near
injection sites with investigator approval)

- Inhaled corticosteroids (allowed for chronic obstructive pulmonary disease)

- Azathioprine

- Cyclosporine

- More than 28 days since participation in another investigational drug study

- Recovered from prior radiotherapy

- No planned or elective anticancer surgical treatment including target lesion
intervention

- Concurrent radiotherapy allowed for treatment of bone lesions

- Concurrent bisphosphonates allowed