A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
aldesleukin
Anemia+13
+ Enfermedades de la Médula Ósea
+ Enfermedad Crónica
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 1996
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS). Evaluate the hematologic effects of subcutaneous IL-2 in MDS. OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially. Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued. PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 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 15 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 myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) No patients with refractory anemia with excess blasts in transformation (RAEB-t) PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Karnofsky 70-100 Hematopoietic: Platelet count greater than 20,000 Hepatic: Bilirubin less than 1.6 mg/dL SGOT less than 150 U/L Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension Pulmonary: No significant pleural effusion, dyspnea at rest or severe exertional dyspnea Other: No patients with nephrotic syndrome No uncontrolled infections or active peptic ulcer disease No serious intercurrent medical illness Not pregnant or nursing Adequate contraception required of all patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunosuppressive therapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since corticosteroid therapy At least 4 weeks since other endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy 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
University of Washington Medical Center
Seattle, United StatesAbrir University of Washington Medical Center en Google Maps