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- Ensaio Clínico NCT00058019
Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
Patients are followed every 8 weeks until disease progression.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
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Texas
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Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
- Grade III follicular center
- Diffuse large B-cell
- Mantle cell
- Primary mediastinal B-cell
- Burkitt's
- High-grade B-cell (Burkitt-like)
Anaplastic large cell of 1 of the following subtypes:
- CD30-positive
- T-cell
- Null cell
- Hodgkin's-like
Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
- Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
- No progressive disease after the most recent prior therapy
Measurable disease
- At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam
Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
- Patients requiring debulking prior to transplant allowed
No known CNS involvement by lymphoma
- Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator
- Performance status - ECOG 0-2
- More than 3 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550
- No peripheral neuropathy grade 2 or greater
- No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse)
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy
- No CSFs during first course of study therapy
- No concurrent filgrastim-SD/01
- No concurrent immunotherapy
- See Disease Characteristics
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- No concurrent hormonal therapy
- At least 4 weeks since prior radiotherapy
- No concurrent therapeutic radiotherapy
- At least 4 weeks since prior surgery
- Recovered from prior therapy
- At least 7 days since prior cimetidine
- No concurrent cimetidine
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer medications
- No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Treatment (chemotherapy)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
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Dado IV
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Objective Overall Response Rate
Prazo: up to 3 years
|
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment.
CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
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up to 3 years
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Safety and Toxicity of Ixabepilone
Prazo: up to 3 years
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Number of patients experiencing adverse event grade 3 or above.
Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0.
Adverse events possibly, probably, or definitely attributed to use of ixabepilone.
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up to 3 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Duration of Response
Prazo: up to 3 years
|
Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented.
According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
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up to 3 years
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Overall Survival
Prazo: up to 3 years
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Defined as the time from the first day of therapy to the date of death.
If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.
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up to 3 years
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Time to Progression
Prazo: up to 3 years
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Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported.
Patients who died without a reported prior progression was considered to have progressed on the day of their death.
Patients who did not progress was censored at the day of their last tumor assessment.
According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
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up to 3 years
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (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
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças Virais
- Infecções
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Atributos da doença
- Infecções por vírus de DNA
- Infecções por Vírus Tumorais
- Infecções pelo vírus Epstein-Barr
- Infecções Herpesviridae
- Linfoma de Células B
- Linfoma de Células T
- Linfoma
- Linfoma de Células B Grandes Difuso
- Recorrência
- Linfoma Não-Hodgkin
- Linfoma de Burkitt
- Linfoma de Células do Manto
- Linfoma de Células Grandes Anaplásico
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Epotilonas
- Epotilona B
Outros números de identificação do estudo
- NCI-2009-00031 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Concessão/Contrato do NIH dos EUA)
- N01CM62202 (Concessão/Contrato do NIH dos EUA)
- P30CA014599 (Concessão/Contrato do NIH dos EUA)
- NCI-5913
- UCCRC-NCI-5913
- CDR0000285683
- UCCRC-11965B
- 11965B (Outro identificador: University of Chicago)
- 5913 (CTEP)
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