A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase
becatecarin
+ laboratory biomarker analysis
Anemia+25
+ Anemia Refractaria con Exceso de Blastos
+ Transformación Celular Neoplásica
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue (XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase. OUTLINE: This is a dose-escalation study. Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients achieving a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 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
Inclusion Criteria: * Diagnosis of 1 of the following: * Acute myeloid leukemia * Myelodysplastic syndromes, including 1 of the following: * Refractory anemia with excess blasts (RAEB) * RAEB in transformation * Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts * Acute lymphoblastic leukemia * Chronic myelogenous leukemia in blastic phase * Relapsed or refractory disease, defined as 1 of the following: * Failed to achieve a complete response (CR) to a standard induction regimen * Relapsed after achieving a CR * Failed last cytotoxic regimen before study entry * No alternate, potentially curative option available * No known CNS disease * Performance status - ECOG 0-2 * SGOT and SGPT normal * Bilirubin normal * Creatinine normal * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119) * No concurrent uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No prior allogeneic stem cell transplantation * No concurrent prophylactic hematopoietic colony-stimulating factors (CSF) * No epoetin alfa or hematopoietic CSF during course 1 of study therapy * More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea * More than 7 days since prior radiotherapy * Recovered from all prior therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents or therapies * No other concurrent antileukemic agents or therapies * No other concurrent investigational agents or therapies * No other concurrent cytotoxic agents
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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