Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

30 de junio de 2015 actualizado por: Active Biotech AB

A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

526

Fase

  • Fase 2
  • Fase 3

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

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
      • Plovdiv, Bulgaria, 4004
        • 1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
      • Sofia, Bulgaria, 1431
        • Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
      • Sofia, Bulgaria, 1527
        • Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
      • Varna, Bulgaria, 9002
        • Urology Clinic, General Hospital for Active Treatment "St. Anna"
      • Veliko Tarnovo, Bulgaria, 5000
        • Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
  • Federación Rusa
      • Arkhangelsk, Federación Rusa
        • Arkhangelsk Regional Oncology Center
      • Chelyabinsk, Federación Rusa, 454087
        • Chelyabinsk Regional Oncology Center
      • Kazan, Federación Rusa, 420029
        • Republican Clinical Oncology Center
      • Kazan, Federación Rusa, 420111
        • Kazan City Oncology Center
      • Moscow, Federación Rusa, 115478
        • Russian Oncological Research Center n.a. N.N. Blokhin
      • Moscow, Federación Rusa, 105425
        • Research Institute of Urology
      • Moscow, Federación Rusa, 117997
        • Russian Research Center of Radiology
      • Obninsk, Federación Rusa, 249036
        • Medical Radiology Research Center
      • Orenburg, Federación Rusa, 460021
        • Orenburg Regional Clinical Oncology Center
      • St. Petersburg, Federación Rusa, 191104
        • Leningrad Regional Oncological Center
      • St. Petersburg, Federación Rusa, 193312
        • Municipal Aleksandrovskaya Hospital
      • St. Petersburg, Federación Rusa, 194354
        • Municipal Multi-Speciality Hospital #2
      • St. Petersburg, Federación Rusa, 196247
        • Municipal Hospital #26
      • St. Petersburg, Federación Rusa, 197022
        • Municipal Clinical Oncology Center
      • St. Petersburg, Federación Rusa, 197758
        • Central Research Institute of Roentgenology and Radiology
      • St. Petersburg, Federación Rusa, 197758
        • Research Institute of Oncology n.a. Professor N.N. Petrov
      • St. Petersburg, Federación Rusa, 198205
        • Municipal Hospital #15
      • Stavropol, Federación Rusa, 355047
        • Stavropol Territorial Clinical Oncology Center
      • Yaroslavl, Federación Rusa, 150054
        • Regional Clinical Oncology Hospital
  • Reino Unido
      • Cambridge, Reino Unido, CB2 0QQ
        • Addenbrooke's Hospital, Cambridge Clinical Trials Centre
      • Derby, Reino Unido, DE1 2QY
        • Derby Hospital NHS Trust
      • Glasgow, Reino Unido, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • Leeds, Reino Unido, LS9 7TF
        • St. James's Institute of Oncology
      • London, Reino Unido, SW6 6JJ
        • The Royal Marsden NHS Trust
      • Manchester, Reino Unido, M20 4BX
        • The Christie Hospital NHS Trust
      • Swansea, Reino Unido, SA2 8QA
        • South Wales Cancer Institute, Singleton Hospital
  • Rumania
      • Bucharest, Rumania, 022328
        • Fundeni Clinical Institute - Urology Department
      • Bucharest, Rumania, 041345
        • Dinu Uromedica
      • Bucharest, Rumania, 050659
        • "Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
      • Cluj Napoca, Rumania, 400015
        • "I. Chiricuta" Institute of Oncology
      • Cluj Napoca, Rumania, 400016
        • E-URO Medical Center
      • Constanta, Rumania, 900635
        • Provita Center SRL
      • Sibiu, Rumania, 550245
        • Sibiu Clinical Country Hospital - Urology Clinic
      • Timisoara, Rumania, 300239
        • Oncomed SRL
  • Ucrania
      • Cherkassy, Ucrania, 18009
        • Cherkassy Regional Oncology Center
      • Chernigov, Ucrania, 14029
        • Chernigov Regional Oncology Center
      • Dnepropetrovsk, Ucrania, 49005
        • Urology Department, Dnepropetrovsk State Medical Academy
      • Dnepropetrovsk, Ucrania, 49102
        • City General Hospital #4
      • Donetsk, Ucrania, 83092
        • Donetsk Regional Antitumor Center
      • Ivano-Frankovsk, Ucrania, 76000
        • Ivano-Frankovsk Regional Oncology Center
      • Kharkiv, Ucrania, 61037
        • Kharkiv Regional Urology and Nephrology Center
      • Kiev, Ucrania, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology
      • Kiev, Ucrania, 04053
        • Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department
      • Lvov, Ucrania, 79031
        • State Regional Diagnostics and Treatment Oncology Center
      • Uzhorod, Ucrania, 88014
        • Regional Oncology 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:

  • Histologically or cytologically confirmed RCC (clear cell and papillary types)
  • Metastatic or inoperable locally advanced RCC
  • Eligible for therapy with IFN-alpha.
  • Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
  • Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
  • Karnofsky performance status greater than or equal to 70
  • Age greater than or equal to 18
  • Life expectancy greater than 3 months

  • Baseline blood counts:

    • Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
    • Platelets greater than or equal to 100 x 10^9/L
    • Haemoglobin greater than or equal to 100 g/L

  • Baseline blood chemistry levels:

    • Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
    • Bilirubin less than or equal to 2 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. AST and ALT allowed less than or equal to 5 x ULN for patients with liver metastases.
  • If fertile, patient will use effective method of contraception throughout the study
  • Willing and able to comply with the treatment and follow-up visits and examinations
  • Capable of understanding the parameters in the protocol and able to sign a written consent form

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
  • History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
  • History and/or signs of parenchymal brain metastases
  • Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
  • History of stroke within 5 years and/or transient ischemic attack within 6 months.
  • Acute illness or evidence of infection, including unexplained fever (>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
  • Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
  • Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
  • Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
  • Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
  • Known positive serology for HIV
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
  • Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
  • Radiotherapy less than 4 weeks before start of treatment
  • Major surgery or tumor embolization less than 4 weeks before start of treatment
  • Previous exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins
  • Currently on renal dialysis treatment
  • Known allergy or hypersensitivity to aminoglycosides and kanamycin
  • Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-alpha or IL-2 or any chemotherapy) except sunitinib or other oral antiangiogenic therapy
  • Participation in any study with investigational drugs for RCC within 6 weeks

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
Experimental: 1
Droga: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Otros nombres:
  • naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Otros nombres:
  • Referon-A
Experimental: Safety group
6-12 patients
Droga: ABR-217620/naptumomab estafenatox
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
Otros nombres:
  • naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Otros nombres:
  • Referon-A
Otro: 2
Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox
Droga: IFN-alpha
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Otros nombres:
  • Referon-A

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Time to death
Periodo de tiempo: every 12 weeks, including after a maximum of 18 months of study treatment
every 12 weeks, including after a maximum of 18 months of study treatment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Progression-free survival time
Periodo de tiempo: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
Objective tumor response rate
Periodo de tiempo: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Best overall response
Periodo de tiempo: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Duration of response
Periodo de tiempo: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Changes in sum of target lesions
Periodo de tiempo: every 12 weeks for the 18-month treatment period
every 12 weeks for the 18-month treatment period
Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha
Periodo de tiempo: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Vital signs
Periodo de tiempo: every visit through Week 25, plus Week 73
every visit through Week 25, plus Week 73
Physical measurements
Periodo de tiempo: Weeks 1, 9, 17, 25, 73
Weeks 1, 9, 17, 25, 73
Adverse events
Periodo de tiempo: every visit through Week 73
every visit through Week 73
Laboratory safety assessments
Periodo de tiempo: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Periodo de tiempo: Weeks 1, 9, and 17
Weeks 1, 9, and 17

Colaboradores e Investigadores

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

Patrocinador

Active Biotech AB

Investigadores

  • Director de estudio: Thore Nederman, PhD, Active Biotech AB

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 enero de 2007

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de enero de 2013

Fechas de registro del estudio

Enviado por primera vez

9 de enero de 2007

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2007

Publicado por primera vez (Estimar)

11 de enero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de julio de 2015

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

30 de junio de 2015

Última verificación

1 de junio de 2014

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 06762004

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. .

Suscribir