- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00045695
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canadá, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London, Ontario, Canadá, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto, Ontario, Canadá, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canadá, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 4H4
- Saskatoon Cancer Centre
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-
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Illinois
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Hinsdale, Illinois, Estados Unidos, 60521
- Hinsdale Hematology Oncology Associates
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4283
- Abramson Cancer Center at the University of Pennsylvania
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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:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
- Newly diagnosed or untreated with IgM ≥ 20 g/L OR
- Previously treated with IgM ≥ 5 g/L
- Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
Must have 1 or more of the following:
- Symptomatic lymphadenopathy
- Hepatomegaly and/or splenomegaly
- Anemia (i.e., hemoglobin < 11.0 g/dL)
- Hyperviscosity syndrome
- No other lymphoproliferative disease including transformed aggressive lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- No uncontrolled bacterial, fungal, or viral infection
- No pre-existing sensory or motor neurotoxicity grade 2 or greater
- No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
- No other serious illness or medical condition that would preclude study participation
- No unreasonable geographical limitations
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- See Disease Characteristics
- At least 12 weeks since prior rituximab (for patients who have progressed)
- At least 24 weeks since prior rituximab (for patients who have not progressed)
- No prior high-dose chemotherapy and stem cell transplantation
- No prior radioactive monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No more than 2 prior chemotherapy regimens
- The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- Single-agent rituximab not considered 1 prior regimen
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since prior plasmapheresis
- At least 4 weeks since prior investigational anticancer therapy
- No other concurrent investigational anticancer agents or therapies
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Response rate
Periodo de tiempo: 4 years
|
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
|
4 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Toxicity
Periodo de tiempo: 4 years
|
To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
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4 years
|
Cytogenetics and genome profiling
Periodo de tiempo: 4 years
|
To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
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4 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Christine I. Chen, MD, Princess Margaret Hospital, Canada
Publicaciones y enlaces útiles
Publicaciones Generales
- Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.
- Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Neoplasias De Células Plasmáticas
- Macroglobulinemia de Waldenström
- Agentes antineoplásicos
- Bortezomib
Otros números de identificación del estudio
- I152
- CAN-NCIC-IND152
- ECOG-JI152
- NCI-NCIC-152
- CDR0000257042 (Otro identificador: PDQ)
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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