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Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma

13 de septiembre de 2016 actualizado por: Laura Kulik, Northwestern University

A Single-Center Proof of Concept Pilot Study to Evaluate the Safety, Efficacy, and Tolerability of Sorafenib Combined With Therasphere in Subjects With Hepatocellular Carcinoma Awaiting Liver Transplantation.

A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Because Hepatocellular carcinoma (HCC) grows by forming new blood vessels liver transplant (OLT) offers the best chance for long term survival. However, with the growing number of patients who require OLT, prolonged wait list times often lead to drop out from the transplant list due to tumor progression. Some patients are granted an "upgrade",within the generally accepted guidelines for transplant eligibility, in order to expedite the access of patients with early HCC to transplantation before tumor progression. The use of therapies like radioembolization also known as Yttrium-90 ([Y-90] a procedure where very small beads coated with radiation are injected directly into the tumor through an artery in your groin) while awaiting OLT has become common at most transplant centers, including Northwestern, to help patients reach transplant. Additionally, these treatments are being used to move patients to a status eligible for transplant. We are studying whether a combination approach with systemic therapy and therapy applied directly to the liver, will be more successful than a single therapy . Angiogenesis (a process involving the growth of new blood vessels from pre-existing vessels) plays an important role in the early stages of HCC. A decrease in angiogenesis both locally within the treated tumor as well as in any existing tumor cells, not yet detected, would hopefully decrease the incidence of post transplant recurrence of HCC. All subjects enrolled in this study will be treated with the use of Therasphere, Y-90, which is composed of nonbiodegradable glass microspheres coated with the radioactive compound Y-90 which are injected into the hepatic artery. The concentrated radioactive microspheres within the tumor lead to "inside-out" radiation. Half of the subjects will be treated with sorafenib (NEXAVAR®) in conjunction with Y-90. The determination of which subjects will receive sorafenib will be made randomly, like the flip of a coin. Sorafenib works by slowing the growth of the tumor cell , attacking the tumor from the outside. Researchers hope to determine whether the subjects treated with sorafenib have an overall improved response to liver directed therapy with Y-90 Therasphere.

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern Memorial Hospital

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:

  • Adult > 18 years olf of either gender
  • Diagnosis of HCC confirmed by biopsy, CT, or MRI
  • Able to carry out activities of daily living, awake >50% of waking hours
  • Meets eligibility for liver transplantation
  • No prior treatment for HCC
  • Ability to understand and sign the informed consent
  • Child-bearing women and any men agree to use two forms of birth control (one of which should be a barrier method) during the course of therapy and for 8 weeks afterward.

Exclusion Criteria:

  • Less than or = 18 years old
  • Ineligible for transplant due to comorbid disease
  • Renal Failure requiring dialysis of any kind
  • Severe Cardiac disease
  • History of a stroke
  • Evidence of metastatic disease- or tumors that have spread outside the liver
  • Known human immunodeficiency virus (HIV) infection
  • Uncontrolled blood pressure (systolic > 160) despite medication(s)
  • Major surgery within 4 weeks prior to the screening visit
  • Active clinically serious infection
  • Serious non-healing wound, ulcer, or bone fracture.
  • History of gastrointestinal bleeding (GIB) within 6 weeks prior to the screening visit
  • Prior transplant of any kind
  • Must be able to swallow oral pills, tablets or capsules of any size
  • Use of St. John's Wort or rifampin (rifampicin).
  • Currently being treated with Interferon and/or Ribavirin therapy due to the thrombocytopenias, lymphopenias and anemias observed with use of these two medications.
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any malabsorption problem
  • Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test 7 days prior to beginning therapy.
  • No potential living donor transplant (LDT-donor identified and worked up by the time of randomization into this study. If a living donor is later identified- the subject will be allowed to continue in the study. Sorafenib will be stopped at a minimum of 7 days prior to transplant surgery.
  • Active alcohol use, drug use, or a psychiatric disease that would, in the opinion of the PI or a subinvestigator (sub-I), prevent the subject from complying with the study protocol and/or endanger the subject during their participation in the study
  • Inability of the potential subject to read, understand and sign the informed consent document

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?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: A: Y-90 alone
Patients randomized to Arm A will proceed to Y-90 treatment alone in the Northwestern standard of care procedure
Droga: Yttrium-90 (Y-90)
Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion
Otros nombres:
  • Radioembolización
  • Therasphere
Experimental: B: Sorafenib + Y-90
Patients randomized to Arm B will start sorafenib at a dose of 400 mg twice daily for bilirubin ≤ 1.5 x ULN and 200 mg twice daily for bilirubin > 1.5 x ULN to ≤ 3 x ULN. After 14 days of sorafenib therapy (+/- 3 days) patients will proceed to Y-90 in the Northwestern standard of care procedure
Droga: Yttrium-90 (Y-90)
Patients undergo radioembolization with Yttrium 90 microspheres by hepatic artery infusion
Otros nombres:
  • Radioembolización
  • Therasphere
Droga: Sorafenib
Randomized to Y-90 ± Sorafenib
Otros nombres:
  • BAY 54-9085 is the tosylate salt of BAY 43-9006; NEXAVAR®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To Evaluate sorafenib as an adjunct to Y-90 for control of HCC as a bridge/downstage to transplant
Periodo de tiempo: Up to one year
Subjects randomized to receive Sorafenib take the drug for 2 weeks before treatment with Y90. They have imaging (CT/MRI) 2 weeks after starting Sorafenib then are treated. Post-treatment patients have blood drawn and adverse event evaluation at 2 weeks, 4 weeks, 6 weeks, and then every 6 weeks up to 1 year or time of transplant. Repeat imaging is done at 4 weeks, and then every 3 months post-treatment. Subjects not receiving Sorafenib are treated with Y90 and then are evaluated post-treatment the same as the subjects that receive the drug.
Up to one year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To characterize the toxicity profile of sorafenib and Y90 using NCI CTC toxicity grading scales.
Periodo de tiempo: up to 1 year
Subjects randomized to receive Sorafenib take the drug for 2 weeks before treatment with Y90. They have imaging (CT/MRI) 2 weeks after starting Sorafenib then are treated. Post-treatment patients have blood drawn and adverse event evaluation at 2 weeks, 4 weeks, 6 weeks, and then every 6 weeks up to 1 year or time of transplant. Repeat imaging is done at 4 weeks, and then every 3 months post-treatment. Subjects not receiving Sorafenib are treated with Y90 and then are evaluated post-treatment the same as the subjects that receive the drug.
up to 1 year
To identify predictive and prognostic markers of how the liver cancer will respond to treatment.
Periodo de tiempo: up to 1 year
All subjects are evaluated with lab work and adverse event assessment at 2, 4, and 6 weeks post-treatment, and then every 6 weeks up to 1 year or when they receive transplant.
up to 1 year

Colaboradores e Investigadores

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

Patrocinador

Northwestern University

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Laura Kulik, MD, Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
  • Investigador principal: Riad Salem, MD, Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 febrero de 2009

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de septiembre de 2016

Fechas de registro del estudio

Enviado por primera vez

16 de febrero de 2009

Primero enviado que cumplió con los criterios de control de calidad

17 de febrero de 2009

Publicado por primera vez (Estimar)

18 de febrero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de septiembre de 2016

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

13 de septiembre de 2016

Última verificación

1 de septiembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NU08I4
  • STU00005761 (Otro identificador: Northwestern University IRB)

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. .

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