Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine
QS21
+ bcr-abl peptide vaccine
Enfermedades de la Médula Ósea+10
+ Enfermedad Crónica
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia. Determine the antileukemic effects of vaccination with these peptides in these patients. OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
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.A partir de 16 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 chronic myelogenous leukemia Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint No accelerated or blastic phase Must be in hematologic remission with peripheral WBC less than 20,000/mm^3 PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Absolute granulocyte count greater than 1,200/mm^3 Platelet count greater than 70,000/mm^3 Hemoglobin greater than 9.0 g/dL No active bleeding Hepatic: Bilirubin less than 2.0 mg/dL Lactate dehydrogenase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No uncontrolled active infection requiring antibiotics No other serious illness No immunodeficiency other than from prior bone marrow transplantation Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior allogeneic or autologous bone marrow transplantation Prior vaccination with pentavalent peptide at less than study dose level allowed At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine Concurrent interferon allowed Chemotherapy: At least 2 weeks since prior low-dose subcutaneous cytarabine At least 4 weeks since prior chemotherapy other than hydroxyurea No concurrent chemotherapy except hydroxyurea Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: No concurrent surgery Other: Concurrent imatinib mesylate allowed No other concurrent systemic therapy
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 2 ubicaciones
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google MapsUniversity of Texas - MD Anderson Cancer Center
Houston, United States