Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Blumenthal Cancer Center at Carolinas Medical Center

Status and phase

Unknown

Phase 2

Conditions

Kidney Cancer

Treatments

Biological: aldesleukin

Procedure: conventional surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00002846

CMC-09-95-15B

CDR0000065085

NCI-V96-1038

Details and patient eligibility

About

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

Full description

OBJECTIVES:

Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
Assess the toxicity associated with this treatment.

OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.

Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

Enrollment

14 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent
- No central nervous system or major nerve involvement
- No more than 25% estimated hepatic replacement by tumor on CT or MRI
Measurable disease required

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 80%-100%

Life expectancy:

Greater than 3 months

Hematopoietic:

Platelet count at least 80,000/mm3

Hepatic:

Bilirubin normal
AST and ALT no greater than 3 times normal

Renal:

Creatinine normal

Cardiovascular:

Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)

Pulmonary:

FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)

Other:

No sites of ongoing bleeding
No HIV antibody or AIDS
No hepatitis B antigen
No systemic infection
No requirement for steroids
No psychiatric disease that precludes informed consent or safe administration of immunotherapy
No second malignancy except:
- Basal cell carcinoma
- In situ cervical cancer
- Other cancer provided all evaluable lesions are documented RCC
No pregnant or nursing women
Effective contraception required of fertile women