- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00054405
Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
A Phase I Investigation of IL-12 (NSC 672423)/Pulse IL-2 (Aldesleukin) in Children With Persistent and/or Refractory Neuroblastoma (13623)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
I. Define the maximum tolerated dose and dose-limiting toxicity of interleukin-12 with or without interleukin-2 in patients with refractory or recurrent neuroblastoma.
II. Determine, preliminarily, the antitumor effect of interleukin-12 with or without interleukin-2 in these patients.
III. Evaluate the immunoregulatory activity of interleukin-12 with or without interleukin-2 in these patients.
IV. Evaluate the antiangiogenic activity of interleukin-12 with or without interleukin-2 in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 treatment cohorts.
COHORT A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12.
COHORT B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A.
Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator.
Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD.
Patients are followed at 3 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Estados Unidos, 90027-6016
- New Approaches to Neuroblastoma Treatment (NANT)
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital Stanford University
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San Francisco, California, Estados Unidos, 94143-0875
- University of California at San Francisco - Comprehensive Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- AFLAC Cancer Center and Blood Disorders Service
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Childrens Memorial Hospital
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Riley Hospital for Children
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan University Hospital
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Texas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's Hospital
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Hospital and Clinics
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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:
Diagnosis of neuroblastoma
- Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
Persistent and/or refractory disease, with at least 1 of the following:
- Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
- Progressive disease after nonmyeloablative or myeloablative therapy
Recurrent disease, evidenced by any of the following:
- Biopsy-proven recurrent soft tissue disease
- Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
- Histologically confirmed bone marrow disease
- Progressive or stable disease after at least 1 prior standard salvage regime
- No clinically significant pleural effusion
- ECOG 0-1
- Life expectancy >= 12 weeks
- Hepatitis A antibody negative
Hepatitis B surface antigen negative
- Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
- Hepatitis C virus negative
- No history of congenital or acquired coagulation disorder
- Cardiac function normal by ECG
- No dyspnea at rest
- No exercise intolerance
- Oxygen saturation at least 94% by pulse oximetry
- DLCO greater than 60% of predicted
- FEV1 greater than 70% of predicted
- Negative pregnancy test
- Skull-based bony lesions without space-occupying intracranial extension are allowed
- No prior or concurrent intracranial metastatic disease to the brain parenchyma
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 2 months after study
- No prior hematologic malignancy (including leukemia or lymphoma)
- No history of malignant hyperthermia
- No prior or concurrent autoimmune disease
- No positive direct Coombs testing
- No history of ongoing or intermittent bowel obstruction
- No active infection or other significant systemic illness
- More than 2 weeks since prior fenretinide
- More than 2 weeks since prior 13-cis-retinoic acid
- More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- More than 2 weeks since prior interferons or interleukins
- More than 2 weeks since prior cytokine-fusion proteins
- More than 2 weeks since prior IV immunoglobulin (IVIG)
- No prior interleukin-12
- No concurrent cytokines
- No concurrent fenretinide
- No concurrent 13-cis-retinoic acid
No other concurrent immunomodulators, including:
- G-CSF and GM-CSF
- Interferons
- Other interleukins
- IVIG
- More than 4 weeks since prior chemotherapy
- No other unstable medical condition or critical illness that would preclude study participation
- More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem cell transplantation:
No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation
- More than 2 weeks since prior growth hormones
- More than 4 weeks since prior systemic corticosteroids
- More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral birth control pills)
- No concurrent hormonal therapy (including oral birth control pills)
- No concurrent growth hormones
- No concurrent systemic corticosteroids, except for use in life-threatening complications
- More than 4 weeks since prior radiotherapy
- No prior solid organ transplantation
- More than 4 weeks since prior investigational agents
- No other concurrent investigational agents
- No prior enrollment on COG-A3973, unless disease has progressed
- No history of hemolytic anemia
- Absolute neutrophil count at least 1,500/mm^3 [Note: Independent of growth factor or transfusion support]
- Platelet count at least 75,000/mm^3 [Note: Independent of growth factor or transfusion support]
- AST and ALT less than 2.5 times upper limit of normal
- Bilirubin less than 2.0 mg/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR creatinine normal
- HIV negative
- Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at least 30% by echocardiogram
- No congestive heart failure
- No uncontrolled cardiac arrhythmia
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: Treatment (IL-12, aldesleukin)
Cohort A: Patients receive interleukin-12 (IL-12) IV over 5-15 seconds on days 1, 3, 5, 8, 10, and 12. Cohort B: Patients receive interleukin-2 (IL-2) IV over 15 minutes twice daily on days 1 and 8 and IL-12 IV as in cohort A. Treatment in both cohorts repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Some patients may receive additional courses at the discretion of the principal investigator. Cohorts of 3-6 patients in both cohorts receive escalating doses of IL-2 and IL-12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 8 patients receives IL-12 and IL-2 at the MTD. |
Dado IV
Otros nombres:
Dado IV
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
Periodo de tiempo: 28 days
|
28 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Overall response assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Periodo de tiempo: Up to 3 weeks
|
Up to 3 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jon Wigginton, New Approaches to Neuroblastoma Treatment (NANT)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores Neuroectodérmicos Primitivos
- Tumores Neuroectodérmicos Primitivos Periféricos
- Neuroblastoma
- Efectos fisiológicos de las drogas
- Agentes antiinfecciosos
- Agentes del sistema nervioso periférico
- Agentes Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos no narcóticos
- Agentes antineoplásicos
- Factores inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Adyuvantes, Inmunológicos
- Aldesleukin
- Interleucina-12
- Interleucina-2
Otros números de identificación del estudio
- NCI-2009-00024
- P01CA081403 (Subvención/contrato del NIH de EE. UU.)
- NANT 2001-01
- CDR0000270447 (Identificador de registro: PDQ (Physician Data Query))
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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