- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00139360
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
Descripción general del estudio
Descripción detallada
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Bergen, Noruega, 5020
- Department of Oncology, Haukeland University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
LEVEL A (second line): after confirmed progression on standard first line treatment with dacarbazine.
LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients will be included for first line treatment with bevacizumab
Inclusion Criteria:
- Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
- WHO performance status 0-2
- Age >18 years
- Able to undergo outpatient treatment
- Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
- At least 4 weeks since adjuvant interferon alpha
- Recovered from prior chemotherapy
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
- Minimum required laboratory data:
Hematology: absolute granulocytes > 1.0 x 109/L platelets > 100 x 109/L Biochemistry: bilirubin < 1.5 x upper normal limit serum creatinine within normal limits INR < 1.5
- Before patient registration/randomization, written informed consent must be given according to national and local regulations.
Exclusion Criteria:
- No pregnant or lactating patients can be included
- No prior interferon alpha or IL-2 for metastatic disease
- No more than 1 prior chemotherapy regimen for metastatic disease
- No clinical evidence of coagulopathy
- No brain metastases
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of thrombosis
- No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day)
- No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
- No uncontrolled hypertension
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
Active drug
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Anti angiogenesis treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Clinical Response rates
Periodo de tiempo: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time to progression
Periodo de tiempo: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Overall survival
Periodo de tiempo: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
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Safety data
Periodo de tiempo: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.
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CTCAEv2 side effects
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Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Oddbjorn Straume, MD, PhD, Department of Oncology, Haukeland University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Schuster C, Akslen LA, Straume O. Expression of Heat Shock Protein 27 in Melanoma Metastases Is Associated with Overall Response to Bevacizumab Monotherapy: Analyses of Predictive Markers in a Clinical Phase II Study. PLoS One. 2016 May 11;11(5):e0155242. doi: 10.1371/journal.pone.0155242. eCollection 2016.
- Schuster C, Eikesdal HP, Puntervoll H, Geisler J, Geisler S, Heinrich D, Molven A, Lonning PE, Akslen LA, Straume O. Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension. PLoS One. 2012;7(6):e38364. doi: 10.1371/journal.pone.0038364. Epub 2012 Jun 15.
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
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores neuroendocrinos
- Nevos y Melanomas
- Melanoma
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Bevacizumab
Otros números de identificación del estudio
- NSD-11933
- 94070/013
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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