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Clofarabine in Adult Patients With Advanced Solid Tumors

4 de febrero de 2014 actualizado por: Genzyme, a Sanofi Company

A Phase I and Pharmacokinetic Study of Clofarabine in Adult Patients With Advanced Solid Tumors

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions:

  1. What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
  2. What are the side effects of clofarabine when given on this schedule?
  3. How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
  4. Will clofarabine help treat a specific cancer?

Descripción general del estudio

Tipo de estudio

Intervencionista

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Dallas, Texas, Estados Unidos, 75246
        • Mary Crowley Medical Research Center
      • Tyler, Texas, Estados Unidos, 75702
        • US Oncology Tyler Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Have a pathologic diagnosis of advanced solid tumors
  • After MTD is established, patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Be greater than or equal to 18 years old
  • Not eligible for therapy of higher curative potential
  • Have a Karnofsky Performance Status (KPS) greater than or equal to 70
  • Have an estimated life expectancy of greater than or equal to 12 weeks
  • Have a negative serum or urine pregnancy test within 7 days of study enrollment (if patient is a female of childbearing potential)
  • Male and female patients who are fertile must agree to use an effective barrier method of birth control (latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy
  • Sign a written informed consent form
  • Able to comply with study procedures and follow-up examinations
  • Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: ANC: greater than or equal to 1.5 × 10 9th/L; Platelets: greater than or equal to 100 × 10 9th/L; Serum bilirubin: less than 2.0 mg/dL; AST and ALT: less than 3 x ULN (Institutional Upper Limit of Normal) without liver involvement OR less than 5 x ULN(*) with liver involvement; Serum creatinine: less than 2.0 mg/dL; Echocardiogram shortening fraction: greater than or equal to 28%(Not on pharmacologic support); or Ejection fraction greater than or equal to 50% (Not on pharmacologic support).

Exclusion Criteria:

  • Received previous treatment with clofarabine.
  • Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
  • Prior malignancy with less than a 2-year disease-free interval, except for adequately treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.
  • Are pregnant or lactating.
  • Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
  • Have received any chemotherapy, major surgery, or irradiation, whether conventional or investigational, < 4 weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea) and/or have not recovered from acute toxicities of all previous therapy prior to enrollment.
  • Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study (eg, uncontrolled severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, etc.).
  • Have received prior radiation therapy to greater than or equal to 25% of the bone marrow (eg, no whole pelvic irradiation is allowed) and have not recovered from the acute side effects of radiotherapy.
  • Have received prior radiation therapy to the mediastinal region.
  • Have a broncho-alveolar pattern evident on chest x-ray.
  • Have symptomatic or untreated central nervous system (CNS) metastases.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
The maximum tolerated dose (MTD)/recommended phase II dose (RP2D) is the dose at which less than or equal to 1 of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2002

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

29 de julio de 2005

Primero enviado que cumplió con los criterios de control de calidad

29 de julio de 2005

Publicado por primera vez (Estimar)

2 de agosto de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

4 de febrero de 2014

Última verificación

1 de febrero de 2014

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Tumores sólidos

Ensayos clínicos sobre clofarabina (formulación IV)

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