TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
aldesleukin
+ conventional surgery
Enfermedades Urogenitales+11
+ Adenocarcinoma
+ Carcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1995
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 14 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación