Suspendido

Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

anti-thymocyte globulin

+ filgrastim

+ graft-versus-tumor induction therapy

BiológicoMedicamentoProcedimiento
Quiénes están siendo reclutados

Enfermedades de la Mama+2

+ Neoplasias de la Mama

+ Neoplasias

De 18 a 60 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: julio de 2003
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of California, San Diego
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de julio de 2003

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Primary * Determine the toxicity and tolerability of allogeneic peripheral blood stem cell transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or poor-prognosis metastatic adenocarcinoma of the breast. * Determine the ability of this preparative regimen to facilitate long-term engraftment of allogeneic stem cells and lymphocytes in these patients. * Determine the response in measurable/evaluable disease and its temporal relationship to the preparative chemotherapy used and to the onset of clinical graft-versus-host disease (GVHD) in patients treated with this regimen. Secondary * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the tumor response and its temporal relationship to administration of high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen. * Determine the frequency and durability of the induction of full donor chimerism of lymphocytes in patients treated with this regimen. OUTLINE: This is a nonrandomized, pilot study. * Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4, anti-thymocyte globulin IV over 4 hours on days -7 to -4, and high-dose melphalan IV over 30 minutes on days -3 and -2. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (and then orally when tolerated) every 12 hours beginning on day -4 and tapered after day 42 (if no GVHD occurs) or after day 90 (if grade I acute GVHD occurs). Patients also receive methotrexate IV on days 1, 3, and 6. * Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo allogeneic PBSCT on day 0. Patients also receive filgrastim (G-CSF) IV or subcutaneously beginning on day 0 and continuing until blood counts recover. * Donor lymphocyte infusion (DLI): Patients who show disease progression or fail to achieve full donor type T-cell chimerism (at least 90% donor derived T-cells) by the 90-day assessment posttransplantation, and have no evidence of active GVHD may receive DLI. Patients who have unresponsive disease with no active GVHD receive subsequent DLIs every 6-8 weeks. Patients are followed at 1, 3, 6, 12, 18, 24, 30, and 36 months. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Título OficialPilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer 
NCT00074269
Patrocinador PrincipalUniversity of California, San Diego
Última actualización: 14 de enero de 2026
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 5 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

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 60 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 de la MamaNeoplasias de la MamaNeoplasiasNeoplasias por SitioEnfermedades de la Piel

Criterios

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Metastatic disease * Meets 1 of the following criteria: * Chemotherapy-unresponsive disease defined as 1 of the following: * Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession * Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen * Histologically confirmed tumor involvement on bone marrow biopsy * Measurable or evaluable disease\* defined as the following: * Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI * Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only) * Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: \*Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease * Appropriate candidate for allogeneic stem cell transplantation * No active CNS metastases * Available HLA-identical sibling donor * 6/6 antigen match * Donor CD34 cells at least 2 times 10\^6/kg recipient weight * Hormone receptor status: * Estrogen receptor negative or positive * Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation PATIENT CHARACTERISTICS: Age * 18 to 60 Sex * Female Menopausal status * Not specified Performance status * Karnofsky 70-100% OR * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 1,500/mm\^3 * Platelet count at least 30,000/mm\^3 Hepatic * Bilirubin less than 3 times normal\* * AST and ALT less than 3 times normal\* NOTE: \*Unless abnormality due to malignancy Renal * Creatinine no greater than 1.6 mg/dL Cardiovascular * LVEF greater than 40% by echocardiography or MUGA * No myocardial infarction within the past 6 months Pulmonary * DLCO greater than 40% of predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No serious localized or systemic infection * No hypersensitivity to E. coli-derived products * No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix * No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication * No psychological condition or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent glucocorticoids Radiotherapy * No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy Surgery * Not specified Other * No concurrent immunosuppressive medication

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

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

Suspendido

Rebecca and John Moores UCSD Cancer Center

La Jolla, United StatesVer ubicación
Suspendido1 Centros de Estudio