- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00066508
Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.
Visão geral do estudo
Descrição detalhada
OBJECTIVES:
- Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib.
- Determine the safety and tolerability of this drug in these patients.
- Determine the time to disease progression in patients treated with this drug.
- Determine the possible mechanism of resistance to this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 20 days and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90095
- Jonsson Comprehensive Cancer Center at UCLA
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following:
- Relapsed after prior high-dose chemotherapy with stem cell support
- Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support
Measurable disease
- At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan
- No primary or secondary CNS lymphoma
- No HIV-related lymphoma
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 3 months
Hematopoietic
- Hemoglobin at least 9 g/dL
Absolute neutrophil count at least 1,000/mm^3
- No colony-stimulating factors within 4 weeks before obtaining this result
Platelet count at least 50,000/mm^3
- No platelet transfusion within 4 weeks before obtaining this result
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN
- No active hepatitis B or C viral infection
Renal
- Creatinine no greater than 2 times ULN OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No myocardial infarction within the past 6 months
- No evidence of acute ischemia or new conduction system abnormalities on EKG
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Sodium greater than 130 mEq/L
- HIV negative
- No ongoing or active infection
- No other concurrent uncontrolled illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study compliance
- No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- See Chemotherapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
- More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery unless fully recovered
Other
- Recovered from prior therapy
- No other concurrent investigational agents
- No other concurrent investigational or commercial agents or therapies to treat the malignancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Overall response rate (combined complete response and partial response)
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Medidas de resultados secundários
Medida de resultado |
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Tempo para progressão da doença
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Segurança
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Tolerabilidade
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Possible mechanism of resistance
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Sven De Vos, MD, Jonsson Comprehensive Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDR0000316254
- UCLA-0301090
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