- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Virginia Klimek, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
- linfoma folicular grado 3 recurrente
- Linfoma difuso de células grandes en adultos recidivante
- anemia refractaria con exceso de blastos
- anemia refractaria con exceso de blastos en transformación
- leucemia mielomonocítica crónica
- síndromes mielodisplásicos previamente tratados
- síndromes mielodisplásicos secundarios
- leucemia mieloide aguda en adultos con anomalías 11q23 (MLL)
- leucemia mieloide aguda en adultos con inv(16)(p13;q22)
- leucemia mieloide aguda en adultos con t(15;17)(q22;q12)
- leucemia mieloide aguda en adultos con t(16;16)(p13;q22)
- leucemia mieloide aguda en adultos con t(8;21)(q22;q22)
- leucemia mieloide aguda recurrente en adultos
- leucemia mieloide aguda en adultos no tratada
- Linfoma difuso de células pequeñas hendidas en adultos recidivante
- Linfoma difuso de células mixtas en adultos recidivante
- linfoma folicular grado 1 recurrente
- linfoma folicular grado 2 recurrente
- neoplasia mielodisplásica/mieloproliferativa, inclasificable
- leucemia mieloide crónica atípica, BCR-ABL1 negativo
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Enfermedad
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Condiciones precancerosas
- Linfoma
- Síndrome
- Síndromes mielodisplásicos
- Leucemia
- Preleucemia
- Trastornos mieloproliferativos
- Enfermedades mielodisplásicas-mieloproliferativas
- Agentes antineoplásicos
- Antibióticos, Antineoplásicos
- Romidepsina
Otros números de identificación del estudio
- CDR0000069473
- MSKCC-00116
- NCI-1715
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