TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA
aldesleukin
+ recombinant interferon alfa
+ 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: 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.
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 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
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
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, United StatesAbrir Blumenthal Cancer Center at Carolinas Medical Center en Google Maps