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

Blumenthal Cancer Center at Carolinas Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Kidney Cancer

Interventions

aldesleukinBIOLOGICAL

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Carolinas Medical Center

Charlotte, North Carolina, United States

Data from ClinicalTrials.gov

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