- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00720876
Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
A Phase II Study of Vorinostat (Suberoylanilide Hydroxamic Acid) Plus Rituximab in Indolent Non-Hodgkin's Lymphoma
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with rituximab and to see how well it works in treating patients with indolent non-Hodgkin lymphoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- To evaluate the anti-tumor activity of vorinostat and rituximab, in terms of objective response rate, time to progression, and survival, in patients with indolent non-Hodgkin lymphoma.
- To assess the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Beverly Hills, California, Estados Unidos, 90211
- Tower Cancer Research Foundation
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
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Pasadena, California, Estados Unidos, 91105
- City of Hope Medical Group
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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:
Patients must have histologically or cytologically confirmed indolent Non-Hodgkin's Lymphoma; included in this category are newly diagnosed or relapsed/refractory follicular center lymphomas grade I, II, III, relapsed/refractory marginal zone B-cell lymphoma (nodal and extranodal), relapsed/refractory mantle cell lymphoma
Patients must have measurable disease by computed tomography (CT) scan; positron emission tomography (PET) scan evaluations are desirable but not mandatory, so that patients with negative PET scans but measurable disease by CT are eligible
Patients may have had up to four prior chemotherapeutic regimens; steroids alone and local radiation do not count as regimens (radiotherapy must have been completed at least 14 days prior to starting vorinostat); Rituxan alone does not count as a regimen; however, Bexxar or Zevalin do; for treated patients, the most recent therapy must have failed to induce a complete response (i.e., there is persistent disease by CT or PET), or there must be disease progression or recurrence after the most recent therapy
Patients may be enrolled who relapse after autologous stem cell transplant if they are at least three months after transplant, and after allogeneic transplant if they are at least six month post transplant; to be eligible after either type of transplant, patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
Life expectancy of greater than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 2 (Karnofsky >= 60%)
Absolute neutrophil count >= 1,000/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine up to and including 2 mg/dl
Pre-menopausal women must have a negative serum pregnancy test prior to entry on this study; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy within 4 weeks, or radiotherapy within 2 weeks or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include use of steroids, which may continue until two days prior to enrollment; low dose chlorambucil should be stopped two weeks prior to beginning vorinostat; valproic acid should be stopped at least two weeks prior to enrollment; nitrosoureas and mitomycin should be stopped 6 weeks prior to enrollment
Patients may not be receiving any other investigational agents
Patients with known brain metastases are excluded from this clinical trial unless the metastases are controlled after therapy and have not been treated with steroids within the past two months
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
There must be no plans for the patient to receive concurrent hormonal, biological, or radiation therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if mother is treated with vorinostat
Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible; in addition, HIV patients not receiving combination antiretroviral therapy are also ineligible
Patients with other active malignancies are ineligible for this study
Patients with preexisting or previous coagulation issues are not excluded from study as long as 1) previous pulmonary embolism or deep vein thrombosis have been adequately treated or 2) if they are actively receiving Coumadin or lovenox for anticoagulation; patients who are already on coumadin or lovenox do not need to take additional 40 mg subcutaneous injections daily
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 |
|---|---|
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Experimental: Vorinostat and Rituximab
Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest.
Rituximab intravenously once every three weeks .
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Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Response Rate (Complete and Partial Response)
Periodo de tiempo: After every 3 cycles, up to 1 year after the start of treatment
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Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.
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After every 3 cycles, up to 1 year after the start of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression-free Survival
Periodo de tiempo: Until disease progress\relapse, up to 1 year after the start of treatment
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Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis.
Estimated using the product-limit method of Kaplan and Meier.
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Until disease progress\relapse, up to 1 year after the start of treatment
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Number of Participants With Grade 3 and 4 Toxicities
Periodo de tiempo: 3 weeks after the stop of treatment
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Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment.
Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.
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3 weeks after the stop of treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert Chen, MD, City of Hope Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- linfoma folicular de grado 3 en estadio IV
- linfoma folicular grado 3 recurrente
- linfoma folicular de grado 1 en estadio III
- linfoma folicular de grado 2 en estadio III
- linfoma folicular de grado 3 en estadio III
- linfoma folicular de grado 1 en estadio IV
- linfoma folicular de grado 2 en estadio IV
- linfoma de células del manto en estadio III
- linfoma de células del manto en estadio IV
- linfoma folicular de grado 1 en estadio I
- linfoma folicular de grado 2 en estadio I
- linfoma folicular grado 1 recurrente
- linfoma folicular grado 2 recurrente
- Linfoma folicular grado 1 contiguo en estadio II
- Linfoma folicular grado 2 contiguo en estadio II
- Linfoma folicular grado 1 en estadio II no contiguo
- Linfoma folicular grado 2 no contiguo en estadio II
- Linfoma no contiguo de la zona marginal en estadio II
- linfoma de la zona marginal recurrente
- linfoma de la zona marginal en estadio I
- linfoma de la zona marginal en estadio III
- linfoma de la zona marginal en estadio IV
- Linfoma contiguo de la zona marginal en estadio II
- 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
- Linfoma contiguo de células del manto en estadio II
- Linfoma de células del manto en estadio II no contiguo
- Linfoma folicular grado 3 no contiguo en estadio II
- Linfoma de células del manto en estadio I
- Linfoma folicular grado 3 contiguo en estadio II
- linfoma folicular de grado 3 en estadio I
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Linfoma No Hodgkin
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Factores inmunológicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de histona desacetilasa
- Rituximab
- Vorinostat
Otros números de identificación del estudio
- 07195
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- CDR0000600989 (Identificador de registro: PDQ)
- NCI-2010-00531 (Identificador de registro: NCI CTRP)
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