Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
Colección de datos
Neoplasias+3
+ Neoplasias de Células Germinales y Embrionarias
+ Neoplasias por tipo histológico
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 2004
Fecha en la que se inscribió al primer participante.OBJECTIVES: * Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma. * Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory \[never had disease progression or disease recurrence\] vs secondary refractory \[recurrent disease that did not respond completely to reinduction therapy\]). * Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11. * Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11. Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 74 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma, as defined by 1 of the following: * Histologically confirmed disease * Bone marrow metastases plus high urine catecholamines * High-risk disease meeting 1 of the following stage criteria: * Stage IV, with 1 of the following: * Any age with MYCN amplification * \> 18 months of age without MYCN amplification * Stage III, with both of the following: * Any age with MYCN amplification * Unresectable disease * Stage 4S with MYCN amplification * Measurable or evaluable soft tissue disease * Relapsed disease resistant to standard induction chemotherapy and salvage therapy PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No severe hepatic toxicity ≥ grade 3 Renal * No severe renal toxicity ≥ grade 3 Cardiovascular * No severe cardiac toxicity ≥ grade 3 Pulmonary * No severe pulmonary toxicity ≥ grade 3 Other * Not pregnant * Negative pregnancy test * No severe neurologic toxicity ≥ grade 3 * No severe gastrointestinal toxicity ≥ grade 3 * No other severe major organ dysfunction except ototoxicity * No history of allergy to mouse proteins * No active life-threatening infection * No human anti-mouse antibody titer \> 1,000 ELISA units/mL PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps