A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma
Colección de datos
Enfermedades del colon+19
+ Neoplasias del Colon
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2001
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen. * Determine the maximum tolerated dose of this drug in these patients. * Determine the clinical response of patients treated with this drug. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 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 or cytologically confirmed advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach that is refractory to standard treatment * Overexpression of the Lewis-Y antigen * Measurable or evaluable disease * No CNS metastasis * Metastatic liver disease from primary tumor allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Absolute granulocyte count greater than 1,200/mm\^3 Hepatic: * Bilirubin normal * SGOT and SGPT no greater than 1.5 times upper limit of normal * Hepatitis B or C antigen negative * No liver disease (e.g., alcohol liver disease) * Albumin at least 3.0 g/dL Renal: * Creatinine no greater than 1.4 mg/dL * Creatinine clearance at least 60 mL/min * Proteinuria no greater than 1 g/24 hours (grade II toxicity-like) Cardiovascular: * No prior coronary artery disease * No New York Heart Association class II, III, or IV congestive heart failure * No arrhythmia requiring treatment Pulmonary: * FEV\_1 and FVC greater than 65% predicted Other: * No other concurrent malignancy * No active peptic ulcer disease * No known allergy to omeprazole * No known seizure disorder * No concurrent medical or psychiatric condition that would preclude study participation * No contraindication to pressor therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * At least 3 weeks since prior hormonal therapy Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * Not specified
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
Universitaetsklinikum Freiburg
Freiburg im Breisgau, GermanyAbrir Universitaetsklinikum Freiburg en Google Maps