A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV clear cell renal carcinoma

- At least 1 site of measurable disease

- Meeting criteria for 1 of the following:

- Disease progression after prior interleukin-2 (IL-2)

- Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions

- Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such
that participation in this study is not likely to compromise the patient's
opportunity to receive future high-dose IL-2

- Indolent disease (defined as an increase in tumor size of < 50% within the past
6 months) such that participation in this study is not likely to compromise the
patient's opportunity to receive future high-dose IL-2

- No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal
cancer

PATIENT CHARACTERISTICS:

Age

- 16 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 3 months

Hematopoietic

- WBC ≥ 2,500/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Hematocrit ≥ 30%

Hepatic

- AST ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ ULN (< 3.0 mg/dL for patients with Gilbert's syndrome)

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

Renal

- Creatinine < 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other
cancer from which the patient has been disease free for at least 5 years

- No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)

- No active uncontrolled infection

- No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

- At least 3 weeks since prior immunotherapy for renal cancer

Chemotherapy

- At least 3 weeks since prior chemotherapy for renal cancer

- No concurrent chemotherapy

Endocrine therapy

- At least 3 weeks since prior hormonal therapy for renal cancer

- More than 4 weeks since prior corticosteroids

- No concurrent systemic or topical corticosteroids

Radiotherapy

- At least 3 weeks since prior radiotherapy for renal cancer

Surgery

- Not specified

Other

- Recovered from prior therapy

- At least 3 weeks since other prior therapy for renal cancer

- No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)