Phase I Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) in Patients With Refractory Hematologic Malignancies/Bone Marrow Disorders
tetradecanoylphorbol acetate
Linfadenopatía+62
+ Amiloidosis
+ Anemia
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the maximum tolerated dose and dose limiting toxicity of 12-O-tetradecanoylphorbol-13-acetate (TPA) in patients with relapsed or refractory hematologic malignancies or bone marrow disorders. Determine the pharmacokinetics of TPA in these patients. Determine the effects of TPA on the cellular composition of blood and bone marrow in these patients. OUTLINE: This is a dose-escalation study. Patients receive 12-O-tetradecanoylphorbol-13-acetate (TPA) IV over 1 hour on days 1 and 8 followed by 2 weeks of rest. Courses repeat in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of TPA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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 proven relapsed or refractory hematologic malignancy or bone marrow disorder for which there is no standard curative therapy, including, but not limited to: Myelodysplasia Multiple myeloma Myeloproliferative syndrome Chronic lymphocytic leukemia Aplastic anemia Non-Hodgkin's lymphoma Acute leukemia Hodgkin's lymphoma Chronic myelogenous leukemia PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 1 month Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction greater than 40% Pulmonary: FEV_1 greater than 50% predicted Other: No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 10 weeks after study participation No uncontrolled psychiatric or medical illness PRIOR CONCURRENT THERAPY: Biologic therapy: Greater than 3 weeks since prior biologic therapy Chemotherapy: Greater than 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational agents
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
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, United StatesAbrir Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School en Google Maps