Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
aldesleukin
+ daclizumab
Enfermedades de la Médula Ósea+17
+ Enfermedad Crónica
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma. Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution. Evaluate the immunogenicity of HAT. Identify immunologic parameters that correlate with efficacy. Evaluate the preliminary efficacy of HAT in these patients. Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability). OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia). Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies. Patients are followed weekly for 2 months. PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML 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 25 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 diagnosis of one of the following malignancies: Hodgkin's lymphoma Acute myelogenous leukemia Chronic myelogenous leukemia Failed standard therapy or in chronic phase if on standard therapy At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells Measurable disease No symptomatic CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Life expectancy: Greater than 2 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times normal No significant hepatic disease Renal: Creatinine no greater than 3 times normal No significant renal disease Cardiovascular: No significant cardiovascular disease Pulmonary: No significant pulmonary disease Other: No significant endocrine, rheumatologic, or allergic disease No HIV-I antibody No active disease due to any of the following: Cytomegalovirus Herpes simplex virus I/II Hepatitis B or C Tuberculosis Negative pregnancy test required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine anti-Tac monoclonal antibody Chemotherapy: At least 4 weeks since chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Surgery: Not specified Other: Concurrent treatment allowed for complications of primary disease
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
Beth Israel Deaconess Medical Center
Boston, United StatesAbrir Beth Israel Deaconess Medical Center en Google Maps