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Eficacia Terapéutica de (90)Itrio-marcado Anti-Tac en Malignidades Linfoides CD25 Positivas

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Objetivo del estudio

Este estudio tiene como objetivo determinar la dosis máxima tolerada y evaluar la respuesta clínica del (90)Itrio-marcado Anti-Tac en el tratamiento de malignidades linfoides CD25 positivas.

Qué se está evaluando

Tratamiento con Y-90 Anti-Tac Humanizado

+ Eliminación de Agente Radioactivo con Calcio-DTPA

BiológicoMedicamento
Quiénes están siendo reclutados

Enfermedades hemáticas y linfáticas+7

+ Enfermedades del sistema inmunitario

+ Trastornos Inmunoproliferativos

De 18 a 80 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1 & 2
Intervencional
Inicio del estudio: abril de 1997
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 7 de diciembre de 2015
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de abril de 1997

Fecha en la que se inscribió al primer participante.

Background: Cluster of differentiation 25 (CD25) is expressed on the malignant cells of patients with certain lymphoid malignancies as well as the non-malignant T cells that surround the malignant tumor cells of patients with Hodgkin's disease. Zenapax is a humanized monoclonal antibody that binds to CD25. Zenapax has been chemically modified by the addition of a chelating molecule to permit binding of radioactive yttrium. The yttrium labeled Zenapax binds to CD25 to deliver radiation treatment to the tumor. Objective: To assess the toxicity and therapeutic efficacy of (90)Yttrium-labeled humanized anti-Tac((90)Y-HAT) in patients with Tac-expressing hematologic malignancies. To determine the sites of localization of radiolabeled Zenapax. Eligibility: Patients with Hodgkin's disease and other CD25 positive lymphoid malignancies. The patient must have a granulocyte of at least 1,200/mm^3 and a platelet count of greater than 100,000/mm^3. Design: Patients will be treated with 10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled Zenapax. Indium labeled Zenapax is given to demonstrate the antibody distribution and confirm localization at sites of tumor. Treatment is given every six weeks if tolerated and patients will be hospitalized for about one week for each treatment. Tumor response will be evaluated after every treatment. Stable or responding patients will continue treatment with evaluations after every cycle of treatment. Patients will be treated for up to seven cycles.

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 7 de diciembre de 2015
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 87 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 80 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

Enfermedades hemáticas y linfáticasEnfermedades del sistema inmunitarioTrastornos InmunoproliferativosEnfermedades LinfáticasLinfomaTrastornos LinfoproliferativosNeoplasiasNeoplasias por tipo histológicoEnfermedad de HodgkinLinfoma no Hodgkin

Criterios

INCLUSION CRITERIA: All patients must have a histologically confirmed diagnosis of Hodgkin's disease. Patients who have had an allogeneic or autologous transplant are eligible if they are more than 100 days post-transplant. At least 10% of each patient's malignant cells from peripheral blood, lymph node, skin, or other extranodal sites must react with anti-Tac, as determined by immunofluorescent or immunoperoxidase staining. Because of the high incidence of Tac positivity in infiltrating T cells in Hodgkin's disease, patients with cluster of differentiation 25 (CD25) positive infiltrating T cells will be eligible even if the Hodgkin's cells are negative. Diagnoses and Stage Disease: 1) Non-Hodgkin's Lymphoma (NHL): Patients with all histopathologic subtypes of Tac-expressing NHL are eligible. Patients with indolent NHL Stages II through IV are eligible if they have failed at least one standard therapy and have disease requiring treatment. Patients with aggressive NHL are eligible if they have relapse after standard chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation. 2) Hodgkin's disease: Patients who are considered to have a low potential for cure with conventional chemotherapy or radiation therapy are eligible. Specifically, patients with stages II-IV Hodgkin's disease are eligible if they have relapsed or failed to attain a complete remission after first-line chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation. 3) Cutaneous T-cell Lymphoma (CTCL): Patients with all stages of Tac-expressing CTCL are eligible with the exception of Stage Ia. Patients with Stages Ib through III are eligible if they have failed at least one standard therapy. Patients with stage IV are eligible regardless of whether they have had previous therapy. 4) Peripheral T-cell Lymphoma (PTCL): Patients with stages I - IV PTCL are eligible if they have relapsed after first-line chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation. Other: Patients with lymphoid leukemias or lymphomas not easily classified in the above categories will be eligible providing they have failed standard therapy and are not eligible for or have refused bone marrow transplantation. Patients must have a Karnofsky performance status of at least 50. Patients must have a creatinine of less than 2.0 mg/dl. If they patient has an abnormally elevated creatinine a creatinine clearance must be greater than 50 ml/min. Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 5 times the upper limit of normal, bilirubin less than 3.0 unless this is felt to be due to the malignancy. Patients must not have clinical cardiac failure. Patients with symptomatic pulmonary dysfunction are eligible only if it is due to the underlying malignancy. The patient must have a granulocyte count of at least 1,200/mm^3 and a platelet count of greater than 100,000/mm^3. Patients must be able to understand and sign informed consent. Breast-feeding females are not eligible for the study. Omission of cytotoxic chemotherapy or other systemic therapy of the malignancy for 3 weeks prior to entry into trial. However, patients receiving corticosteroids will not be excluded. Patients receiving corticosteroids must be on a stable dose for at least three weeks before receiving yttrium 90-labeled humanized anti-Tac (90Y-HAT) on this study. Patients must have a life expectancy of greater than 1 month. Patients must be at least 18 years old. EXCLUSION CRITERIA: Female patients of child bearing potential will be tested for pregnancy; pregnant patients will be excluded from the study. Patients who are human immunodeficiency virus (HIV) antibody positive. Patients with symptomatic disease that is due to malignant involvement of the central nervous system. Patients with active second primary cancer. Patients receiving chronic anticoagulant therapy will be excluded from the study. Patients requiring urgent chemotherapy or radiation therapy for management of their malignancy will be excluded. Patients with evidence of myelodysplastic syndrome or chromosomal abnormalities in their screening bone marrow evaluation

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA). Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Objetivos 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 una ubicación

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesAbrir National Institutes of Health Clinical Center, 9000 Rockville Pike en Google Maps
Completado1 Centros de Estudio