- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00538187
Obatoclax and Bortezomib in Treating Patients With Aggressive Relapsed or Recurrent Non-Hodgkin Lymphoma
Phase I Study of GX15-070 (NSC # 729280) and Bortezomib in Aggressive Relapsed/Recurrent Non-Hodgkin's Lymphoma
Descripción general del estudio
Estado
Condiciones
- Linfoma difuso de células grandes en adultos recidivante
- Linfoma folicular de grado 1 recidivante
- Linfoma folicular de grado 2 recidivante
- Linfoma folicular de grado 3 recidivante
- Linfoma de células del manto recidivante
- Linfoma recidivante de la zona marginal
- Linfoma de linfocitos pequeños recidivante
- Linfoma no Hodgkin en adultos
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose of obatoclax mesylate when administered with bortezomib in patients with aggressive relapsed or recurrent non-Hodgkin lymphoma.
II. To describe the toxicities of this regimen at each dose studied in these patients.
III. To characterize the pharmacokinetic behavior of this regimen in these patients.
IV. To obtain preliminary information regarding the effect of obatoclax mesylate on several apoptotic regulatory pathways.
V. To document all clinical responses in these patients to this regimen.
OUTLINE: This is a multicenter study.
PHASE I: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on days 1, 8, 15, and 22.
Treatment repeats every 35 days in the absence of disease progression or unacceptable toxicity. Pharmacokinetic evaluations of obatoclax mesylate are conducted in all patients during the first course.
PHASE II: Patients receive obatoclax mesylate IV over 3 hours followed by bortezomib IV on days 1, 8, 15, and 22 at the maximum tolerated dose determined in phase I.
Treatment repeats every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 26 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Histologically or cytologically confirmed relapsed or refractory non-Hodgkin lymphoma for which standard curative or palliative measures do not exist or are no longer effective, including any of the following subtypes:
- Follicular grade I, II, or III lymphoma
- Marginal zone lymphoma
- Mantle cell lymphoma
- Diffuse large B cell lymphoma
- Small lymphocytic lymphoma
Must have had at least one prior chemotherapeutic regimen:
- Steroids or rituximab alone or local radiotherapy do not count as regimens
- Tositumomab or ibritumomab tiuxetan allowed as regimens
- Clear evidence of disease progression or lack of response after the most recent therapy, including rituximab or local radiotherapy, is required
- At least 3 months since prior autologous stem cell transplantation and relapsed (>= 1 year since prior allogeneic transplantation and relapsed) and no active related infections (i.e., fungal or viral)
- In the case of allogeneic transplantation relapse, there should be no active acute graft-versus-host disease (GVHD) of any grade and no chronic GVHD other than mild skin, oral, or ocular GVHD not requiring systemic immunosuppression
- No known active brain metastases, other neurological disorders/dysfunction or history of seizure disorder, or other neurological dysfunction
- Karnofsky performance status 60-100%
- Life expectancy > 3 months
- Total bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine normal or creatinine clearance >= 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for 3 months after the last dose of obatoclax mesylate
- At least 4 weeks since prior radiotherapy
- More than 2 days since prior steroids
- More than 2 weeks since prior low-dose chlorambucil
- WBC >= 3,000/mm^3
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- At least 2 weeks since prior valproic acid
Exclusion Criteria:
Uncontrolled concurrent medical condition or illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia including QTc > 450 msec
- Patients who are intolerant or refractory to prior treatment with bortezomib (refractory is defined as no response to prior treatment with bortezomib)
- Chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- Rituximab within the past 3 months (unless there is evidence of progression)
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Other concurrent investigational agents
- Combination antiretroviral therapy for HIV-positive patients
- No history of allergic reactions attributed to bortezomib, polyethylene glycol (PEG 300), or polysorbate 20
- No psychiatric illness or social situation that would limit compliance with study requirements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Treatment (obatoclax mesylate, bortezomib)
Patients will receive a 3-hour infusion of obatoclax and an infusion of bortezomib once a week for 4 weeks
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Dado IV
Otros nombres:
estudio correlativo
Otros nombres:
estudio correlativo
Dado IV
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maximum tolerated dose of obatoclax mesylate when administered with bortezomib
Periodo de tiempo: 35 days
|
Defined as the highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity.
Graded according to the NCI CTCAE, Version 3.0.
|
35 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Toxicity as assessed by NCI CTCAE version 3.0
Periodo de tiempo: Up to 26 weeks after completion of study treatment
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Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity and nadir or maximum values for the laboratory measures, time of onset (i.e.
course number), duration, and reversibility or outcome.
Tables will be created to summarize these toxicities and side effects by dose and by course.
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Up to 26 weeks after completion of study treatment
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Pharmacokinetics of obatoclax mesylate when administered with bortezomib
Periodo de tiempo: Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours
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Dose 1 of course 1, pre-infusion, 1 and 2 hours into the infusion, immediately prior to the end of the infusion, then at 0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, and 168 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph Tuscano, City of Hope Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Atributos de la enfermedad
- Leucemia Linfoide
- Leucemia
- Leucemia de células B
- Linfoma de células B
- Linfoma
- Linfoma Folicular
- Linfoma de células B grandes, difuso
- Reaparición
- Linfoma No Hodgkin
- Linfoma De Células Del Manto
- Leucemia Linfocítica Crónica De Células B
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Bortezomib
- Obatoclax
Otros números de identificación del estudio
- NCI-2009-00253
- U01CA062505 (Subvención/contrato del NIH de EE. UU.)
- PHI-58
- CDR0000566357
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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