- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00589550
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase I Study Of Peginterferon Alfa-2b (PEG-INTRON) With Sorafenib (Nexavar) In Patients With Unresectable Or Metastatic Clear Cell Renal Carcinoma (RCC).
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Genético: análisis de expresión génica
- Otro: análisis de biomarcadores de laboratorio
- Otro: técnica de inmunoenzimas
- Genético: reacción en cadena de la polimerasa transcriptasa inversa
- Otro: citometría de flujo
- Genético: reacción en cadena de la polimerasa
- Droga: Sorafenib
- Biológico: PEG-interferon alfa-2b
Descripción detallada
OBJECTIVES:
Primary
- To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell carcinoma.
Secondary
- To determine the progression-free survival of patients treated with this regimen.
- To evaluate, in a preliminary manner, the response rate and overall survival of patients treated with this regimen.
- To evaluate the activation of interferon-induced transcription factors in immune cell subsets (including regulatory T cells [T regs]) using a novel flow cytometric assay and correlate this information with clinical outcome.
- To measure circulating levels of IFN-γ and IL-5 for determination of Th1/Th2 status and CD4+, CD25+, and FoxP3 cell number (T regs) in peripheral blood.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, 22, 29, 36, 43, and 50. Patients also receive oral sorafenib tosylate 2-3 times daily on days 15-56 of course 1 and on days 1-56 of all subsequent courses. Courses repeat every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study for correlative laboratory studies. Peripheral blood mononuclear cells are analyzed for STAT proteins (STAT1, STAT2, STAT3, STAT4, STAT5) and CD4+, CD25+, and FoxP3 regulatory T cells by flow cytometric assays. Samples are also analyzed for the presence of VEGF, VEGFR, IFN-γ, and IL-5 by ELISA assays; baseline expression of Jak-STAT signaling intermediates (Jak1, Tyk2, IFNAR, and IRF9) by immunoblot analysis; and interferon-stimulated gene expression by real time PCR and RT-PCR analysis.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan
- No prior treatment except
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 6 months
- Good/intermediate Motzer prognostic status
- ANC ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10.0 g/dL
- Total bilirubin ≤ 2.0 mg/dL
- AST and ALT < 2.5 times normal
- Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
- Calcium < 12 mg/dL (when corrected for serum albumin)
- INR < 1.5 times upper limit of normal
- Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo
- Pulse oximetry ≥ 90% at rest on room air
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of bleeding diathesis
- No uncontrolled coagulation disorders
- No active infections requiring IV antibiotics
- No known HIV, hepatitis C, or hepatitis B
- No autoimmune disease requiring ongoing therapy
- No requirement for adrenal replacement
- No angina (controlled or uncontrolled)
- No uncontrolled hypertension
No history of other major medical illnesses including, but not limited to, any of the following:
- Cardiac ischemia
- Myocardial infarction
- Major cardiac arrhythmias
- Inflammatory bowel disorders
- No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years
- No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe
PRIOR CONCURRENT THERAPY:
No prior treatment for RCC except sunitinib malate
- Patients may have progressed or have been intolerant to sunitinib malate
- No prior systemic treatment for metastatic disease (other than sunitinib malate)
- No prior organ allografts
- At least 2 weeks since prior laparoscopic/robotic surgery
- At least 4 weeks since prior open nephrectomy
- More than 4 weeks since prior and no concurrent radiotherapy or other surgery
- More than 4 weeks since prior systemic steroids
- More than 2 weeks since prior topical, injected, or inhaled steroids
- No concurrent steroid therapy
- No concurrent Hypericum perforatum (St. John's wort)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Peginterferon alfa-2b
Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy.
This will most likely be a Monday or a Tuesday.
Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
|
Otros nombres:
administered SC on day 1 of each week of therapy.
This will most likely be a Monday or a Tuesday.
Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate
Periodo de tiempo: up to 2 months
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up to 2 months
|
Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.
Periodo de tiempo: up to 2 months
|
up to 2 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.
Periodo de tiempo: up to 1 year
|
up to 1 year
|
Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.
Periodo de tiempo: up to 1 year
|
up to 1 year
|
Overall Survival
Periodo de tiempo: up to 1 year
|
up to 1 year
|
Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome
Periodo de tiempo: up to 1 year
|
up to 1 year
|
Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood
Periodo de tiempo: Up to 1 year
|
Up to 1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Thomas E. Olencki, DO, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Agentes antineoplásicos
- Factores inmunológicos
- Inhibidores de la proteína quinasa
- Interferones
- Interferón-alfa
- Sorafenib
- Interferón alfa-2
- Peginterferón alfa-2b
Otros números de identificación del estudio
- OSU-06113
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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