An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
Colección de datos
Enfermedades del sistema inmunitario+4
+ Trastornos Inmunoproliferativos
+ Enfermedades Linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. Secondary * Determine the steady-state pharmacokinetics of this drug in these patients. * Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. * Determine whether antibodies to this drug develop in these patients. * Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive VEGF Trap\* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202) Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.
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.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 non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: * Liver * Soft tissue * Pelvis * Other site that is suitable for delayed contrast-enhancing MRI * Relapsed or refractory disease * Failed all conventional therapeutic options AND not amenable to existing therapeutic options * Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity * No prior or concurrent CNS metastases (brain or leptomeningeal) * No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * No severe or uncontrolled hematologic condition Hepatic * Not specified Renal * No severe or uncontrolled renal condition Cardiovascular * No severe or uncontrolled cardiovascular condition Pulmonary * No severe or uncontrolled pulmonary condition Other * No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition * No other medical or psychiatric condition or adverse social circumstance that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy * Not specified Endocrine therapy * No concurrent adrenal corticosteroids, except low-dose replacement therapy * No concurrent systemic hormonal contraceptive agents Radiotherapy * Not specified Surgery * Not specified Other * No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors * No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin * Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed * No other concurrent standard or investigational agents for this malignancy
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
Vanderbilt-Ingram Cancer Center
Nashville, United States