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

TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2

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.

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.

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interleukin-2 therapy

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 28 days since therapy for RCC