Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.

Detailed Description
-----------------
OBJECTIVES: Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2. Determine the impact of this drug on T-cell number and phenotype in these patients. OUTLINE: This is an open-label study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response may receive additional courses of therapy. Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually until disease progression. PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4 years.

Official Title
-----------------
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

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Biological: ipilimumab


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ipilimumab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent renal cell cancer