Phase II Trial of Atragen and Interferon Alfa-2b in Patients With Advanced Renal Cell Carcinoma
recombinant interferon alfa
+ tretinoin liposome
Enfermedades Urogenitales+11
+ Adenocarcinoma
+ Carcinoma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b. Determine the toxicity of this regimen in these patients. Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies. OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.) Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.) During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.) Patients are followed at 30 days after the last treatment. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 26 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.De 18 a 120 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 metastatic renal cell carcinoma Bidimensionally measurable disease No active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 No coagulation disorders Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal No clinically significant hepatic disease, including autoimmune hepatitis Renal: Creatinine less than 2 mg/dL OR Creatinine clearance greater than 50 mL/min No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease No thrombophlebitis Pulmonary: No severe debilitating pulmonary disease No pulmonary embolism Other: No history of diabetes mellitus prone to ketoacidosis No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study No thyroid abnormalities that hinder maintaining thyroid function at the normal range No severe infection No severe malnutrition No clinically significant retinal abnormalities No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biological response modifier therapy or immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery Other: No prior retinoid therapy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 2 ubicaciones
New York Weill Cornell Cancer Center at Cornell University
New York, United StatesAbrir New York Weill Cornell Cancer Center at Cornell University en Google MapsHerbert Irving Comprehensive Cancer Center at Columbia University
New York, United States