- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00042822
FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
A Pilot Study Of FR901228, Or Depsipeptide (NSC #630176) For Adult Patients With Advanced Hematologic Cancers
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).
- Determine the disease response in patients treated with this drug.
- Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients.
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering 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
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Histologically confirmed refractory or relapsed acute myeloid leukemia (AML)
- Failed anthracycline-based chemotherapy
- Ineligible for or refused allogeneic stem cell transplantation
Elderly patients with newly diagnosed AML
- Ineligible for or refused standard chemotherapy
Histologically confirmed high-risk myelodysplastic syndromes
Eligible subtypes include:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Ineligible for or refused allogeneic bone marrow transplantation
Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)
- Relapsed after high-dose therapy OR
- Ineligible for allogeneic or autologous stem cell transplantation
- Evaluable lesions by radiologic study or physical examination
Histologically confirmed follicular NHL
- Progressed after anthracycline-based chemotherapy and rituximab
- Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
- SGOT and SGPT less than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- Cardiac ejection fraction greater than 50%
- No cardiac hypertrophy
- No known conduction heart disease
- No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation
- No significant prior heart disease
- No significant prior secondary or tertiary heart block
- No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control
Pulmonary
- No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- Potassium ≥ 4.0 mmol/L (supplementation allowed)
- Magnesium ≥ 2.0 mg/dL (supplementation allowed)
- No other concurrent active malignancy except basal cell skin cancer
- No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF)
- At least 4 weeks since prior cytokines
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior systemic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
No concurrent drugs that may prolong the QTc interval
- FR901228 (depsipeptide) may be administered after a 5-half-life washout period following the use of these drugs
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Virginia Klimek, MD, Memorial Sloan Kettering Cancer Center
Publicações e links úteis
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
- linfoma folicular grau 3 recorrente
- linfoma difuso de grandes células adulto recorrente
- anemia refratária com excesso de blastos
- anemia refratária com excesso de blastos em transformação
- leucemia mielomonocítica crônica
- síndromes mielodisplásicas previamente tratadas
- síndromes mielodisplásicas secundárias
- leucemia mielóide aguda do adulto com anormalidades 11q23 (MLL)
- leucemia mielóide aguda do adulto com inv(16)(p13;q22)
- leucemia mielóide aguda do adulto com t(15;17)(q22;q12)
- leucemia mielóide aguda do adulto com t(16;16)(p13;q22)
- leucemia mielóide aguda do adulto com t(8;21)(q22;q22)
- leucemia mielóide aguda recorrente do adulto
- leucemia mielóide aguda do adulto não tratada
- linfoma difuso de pequenas células clivadas adulto recorrente
- linfoma difuso de células mistas do adulto recorrente
- linfoma folicular grau 1 recorrente
- linfoma folicular grau 2 recorrente
- neoplasia mielodisplásica/mieloproliferativa, inclassificável
- leucemia mielóide crônica atípica, BCR-ABL1 negativo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Neoplasias
- Distúrbios Linfoproliferativos
- Doenças Linfáticas
- Distúrbios imunoproliferativos
- Doença
- Doenças da Medula Óssea
- Doenças Hematológicas
- Condições pré-cancerosas
- Linfoma
- Síndrome
- Síndromes Mielodisplásicas
- Leucemia
- Pré-leucemia
- Distúrbios mieloproliferativos
- Doenças mielodisplásicas-mieloproliferativas
- Agentes Antineoplásicos
- Antibióticos, Antineoplásicos
- Romidepsina
Outros números de identificação do estudo
- CDR0000069473
- MSKCC-00116
- NCI-1715
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