Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
Colección de datos
Enfermedades de la Médula Ósea+8
+ Enfermedad Crónica
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy. OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 weeks. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.
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.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 chronic phase chronic myelogenous leukemia (CML) * Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow * Complete hematologic remission during prior therapy\* as seen on 2 separate blood count analyses, defined by the following: * WBC no greater than 10,000/mm\^3 AND platelet count no greater than 450,000/mm\^3 * Disappearance of all signs and symptoms of disease, including palpable splenomegaly * Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: \*Continuation of therapy that led to complete hematologic remission is required during study participation * Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day * Not in complete cytogenetic remission within 30 days of study entry * Persistent Philadelphia chromosome by bone marrow exam PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled active infective * No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months * No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Prior sargramostim (GM-CSF) allowed * Prior interferon alfa for CML allowed * No prior stem cell transplantation * Concurrent interferon alfa\* for CML allowed NOTE: \*No dose increase during study participation Chemotherapy * At least 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 4 weeks since prior surgery Other * Prior imatinib mesylate for CML allowed * No other concurrent medication for CML * Concurrent imatinib mesylate\* for CML allowed NOTE: \*No dose increase during study participation
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos 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 15 ubicaciones
CCOP - Bay Area Tumor Institute
Oakland, United StatesCCOP - Mount Sinai Medical Center
Miami Beach, United StatesRegional Radiation Oncology Center at Rome
Rome, United States