Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer

National Institutes of Health Clinical Center (CC)

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Biological: ipilimumab

Study type

Interventional

Funder types

NIH

Identifiers

NCT00057889

CDR0000285624

03-C-0094

030094

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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