VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
- Phase II: Patients receive VNP40101M at the MTD determined in phase I.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- M.D. Anderson Cancer Center at University of Texas
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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 1 of the following hematologic malignancies:
Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
- CLL in transformation allowed
- Richter syndrome
- Other refractory lymphoproliferative diseases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
Creatinine ≤ 2.0 mg/dL
- Renal dysfunction due to organ infiltration by disease allowed
- AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
- Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No symptomatic coronary artery disease
- No arrhythmia not controlled by medication
- No uncontrolled, symptomatic congestive heart failure
- No myocardial infarction within the past 3 months
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
- No other concurrent standard or investigational treatment for this cancer
- No other concurrent cytotoxic investigational drugs
- No concurrent disulfiram
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Toxicidad
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Dosis máxima tolerada
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Eficacia
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Bonny L. Johnson, RN, MSN, Vion Pharmaceuticals
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
Otros números de identificación del estudio
- VION-CLI-041
- CDR0000465217 (Identificador de registro: PDQ (Physician Data Query))
- MDA-2005-0249
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