- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00052572
Ixabepilone in Treating Patients With Relapsed or Refractory Lymphoproliferative Disorders
A Multicenter Phase II Study Of BMS 247550 (Epothilone B Analogue) In Indolent Lymphoproliferative Disorders
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed or refractory lymphoproliferative disorders.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
Primary
- Determine the frequency and duration of complete and partial response rates for patients with relapsed or refractory indolent lymphoproliferative disorders treated with ixabepilone.
Secondary
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive ixabepilone IV over 1 hour weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1-1.5 years.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Vermont
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Burlington, Vermont, Estados Unidos, 05401-3498
- Vermont Cancer Center at University of Vermont
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed/recurrent or refractory indolent lymphoproliferative disorder of 1 of the following types:
Chronic lymphocytic leukemia
- Absolute lymphocytosis greater than 5,000/mm^3
- B-cell phenotype (CD 19, 20, or 23 positive) with more than 30% bone marrow lymphocytes
- B-cell small lymphocytic lymphoma
- Marginal zone B-cell lymphoma
- Grade I-III follicle center cell lymphoma
- Waldenstrom's macroglobulinemia
- Mantle cell lymphoma
At least 1 unidimensionally measurable lesion for patients with non-Hodgkin's lymphoma
- At least 2 cm by conventional techniques
No active brain metastases
- Treated CNS disease allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 if there is lymphomatous involvement of the bone marrow)
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN (4 times ULN if there is liver involvement)
Renal
- Creatinine ≤ 2 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No history of orthostatic hypotension
- No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 3 months
- No New York Heart Association class III or IV congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No uncontrolled hypertension requiring manipulation of antihypertensive medications
No evidence of any of the following by echocardiogram:
- Acute ischemia
Significant conduction abnormality
- Bifascicular block
- 2^nd- or 3^rd-degree atrioventricular block
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other immunodeficiency
- No known severe hypersensitivity reaction to agents containing Cremophor EL
- No ongoing or active infection
- Febrile episodes up to 38.5° Celsius allowed in the absence of infection
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No preexisting grade II or greater sensory neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior monoclonal antibodies (unless there is clearly documented evidence of disease progression after therapy)
- At least 3 months since prior radioimmunotherapy
- No prior allogeneic bone marrow transplantation
Chemotherapy
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin, nitrosoureas, or carmustine) and recovered
No more than 4 prior chemotherapy regimens (including high-dose chemotherapy [HDC] for patients with relapsed disease > 100 days after completion of HDC)
- Cytoreduction plus HDC is considered 1 chemotherapy regimen
- No other concurrent chemotherapy
Endocrine therapy
- At least 7 days since prior steroids
Radiotherapy
- More than 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery
Other
- Use of antibiotics for marginal zone lymphoma does not count as a prior therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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La seguridad
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Eficacia
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Medidas de resultado secundarias
Medida de resultado |
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Supervivencia libre de progresión
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Mean and median duration of response
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Mean and median duration of progression-free and overall survival
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Probability of polymerase chain reaction negativity after treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Leucemia linfocítica crónica de células B
- linfoma folicular grado 3 recurrente
- linfoma folicular grado 1 recurrente
- linfoma folicular grado 2 recurrente
- linfoma de la zona marginal recurrente
- linfoma de linfocitos pequeños recurrente
- Linfoma extraganglionar de células B de la zona marginal de tejido linfoide asociado a mucosas
- linfoma de células B de la zona marginal ganglionar
- linfoma esplénico de la zona marginal
- linfoma de células del manto recurrente
- leucemia linfocítica crónica refractaria
- Macroglobulinemia de Waldenström
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000258542
- MSKCC-02046
- NCI-5342
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