Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Blumenthal Cancer Center at Carolinas Medical Center14 enrolled

Overview

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

OBJECTIVES: * Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. * Assess the toxicity of this regimen. OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 14 patients will be entered.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Kidney Cancer

Interventions

aldesleukinBIOLOGICAL

recombinant interferon alfaBIOLOGICAL

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven renal cell cancer that is metastatic * No greater than 50% estimated hepatic replacement by tumor on CT or MRI * No symptomatic involvement of the CNS or a major nerve * Measurable disease required * Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50%-100% Life expectancy: * More than 3 months Hematopoietic: * No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: * AST and ALT no greater than 5 times normal Renal: * Creatinine less than 4.0 mg/dL Cardiovascular: * No symptomatic angina * No untreated coronary artery disease * No refractory arrhythmia * No abnormal left ventricular function Pulmonary: * No dyspnea on minimal exertion Other: * No site of ongoing bleeding * No systemic infection * No HIV antibody * No HBsAg * No requirement for steroids * No psychiatric disease that precludes informed consent or protocol treatment * No second malignancy except: * Basal cell skin carcinoma * Carcinoma in situ of the cervix * Not pregnant or nursing * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interleukin-2 Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 28 days since prior treatment for renal cell cancer

Locations (1)

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Data from ClinicalTrials.gov

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