- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00253474
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)
- Determine the toxicity profile of this drug in these patients.
Secondary
- Obtain, preliminary, information about the efficacy of this drug in these patients.
- Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
- Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.
OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study closed to accrual as of 2/2005.)
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Children's Hospital of Pittsburgh
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Diagnosis of plexiform neurofibroma which is progressive, symptomatic, or life threatening and for which there is no other standard medical management or surgical option
Histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings provided the following are true:
- No clinical observation or scan suggestive of malignant transformation
Meets ≥ 1 of the following diagnostic criteria for neurofibroma type 1 (NF1):
- Six or more cafe-au-lait spots (> 0.5 cm in prepubertal patients or > 1.5 cm in post pubertal patients)
- Freckling in axilla or groin
- Optic glioma
- Two or more Lisch nodules
- A distinctive bony lesion (e.g., dysplasia of the sphenoid bone, dysplasia, or thinning of long bone cortex)
- A first degree relative with NF1
- No history of malignant peripheral nerve sheath tumor
- No active visual pathway glioma
- No active brain tumor or brain metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 12 months
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 10 g/dL
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 1.5 mg/dL
- SGPT ≤ 2 times upper limit of normal
- No significant hepatic dysfunction
Renal
Creatinine based on age as follows:
- ≤ 0.8 mg/dL (for patients age 5 years and under)
- ≤ 1.0 mg/dL (for patients age 6 to 10 years)
- ≤ 1.2 mg/dL (for patients age 11 to 15 years)
- ≤ 1.5 mg/dL (for patients age 16 to 21 years) OR
- Creatinine clearance ≥ 70 mL/min
Cardiovascular
- No significant cardiac dysfunction
- No severe cardiovascular disease
- No cardiac arrhythmia requiring chronic treatment
- No congestive heart failure
- No symptomatic ischemic heart disease
Pulmonary
- No significant pulmonary dysfunction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious infection
- No other significant unrelated systemic illness
- No significant organ dysfunction
- No other malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
- No history of severe psychiatric condition or psychiatric disorder requiring hospitalization
- No history of suicidal ideation or attempt
- No thyroid dysfunction unresponsive to therapy
- No uncontrolled diabetes mellitus
- No history of HIV positivity
- No alcohol or drug abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent colony-stimulating factors (e.g., erythropoietin or filgrastim [G-CSF])
Chemotherapy
- No concurrent chemotherapy for this disease
Endocrine therapy
- No concurrent chronic systemic corticosteroids
- No concurrent hormonal therapy for this disease
Radiotherapy
- No concurrent radiotherapy for this disease
Surgery
- Prior surgery allowed provided it has been at least 21 days since surgery and there is presence of residual tumor
Other
- Recovered from prior therapy
- More than 30 days since prior investigational agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades Neuromusculares
- Neoplasias De Tejido Nervioso
- Enfermedades del Sistema Nervioso Periférico
- Neoplasias del Sistema Nervioso
- Neoplasias de la vaina nerviosa
- Neoplasias del Sistema Nervioso Periférico
- Neurofibroma
- Neurofibroma Plexiforme
- Efectos fisiológicos de las drogas
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes antineoplásicos
- Factores inmunológicos
- Interferones
- Interferón-alfa
- Peginterferón alfa-2a
- Interferón alfa-2
Otros números de identificación del estudio
- 050232
- 05-C-0232
- NCI-P6670
- CDR0000448811
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