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Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma

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Qué se está evaluando

monoclonal antibody 3F8

+ etoposide

+ isotretinoin

BiológicoMedicamento
Quiénes están siendo reclutados

Neoplasias+3

+ Neoplasias por tipo histológico

+ Neoplasias de Células Germinales y Embrionarias

Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: agosto de 1999
Ver detalles del protocolo

Resumen

Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 31 de octubre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de agosto de 1999

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma. Assess progression-free survival in these patients after this treatment. Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients. OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease). Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity. If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first. Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses. PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.

NCT00004110
Patrocinador PrincipalMemorial Sloan Kettering Cancer Center
Última actualización: 31 de octubre de 2013
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

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

NeoplasiasNeoplasias por tipo histológicoNeoplasias de Células Germinales y EmbrionariasNeoplasias glandulares y epitelialesNeoplasias del Tejido NerviosoNeuroblastoma

Criterios

DISEASE CHARACTERISTICS: High-risk neuroblastoma by: Histopathology OR Bone marrow involvement plus elevated urinary catecholamines Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following: N-myc amplification in tumor cells Diploid chromosomal content plus lp loss of heterozygosity in tumor cells Distant skeletal metastases Unresectable primary tumor infiltrating across the midline More than 10% tumor cells in bone marrow Less than 30% chance of long-term progression-free survival Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy No rapidly progressive disease as defined by 1 or more of the following: Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor An opiate requirement for pain from tumor Greater than 25% increase in tumor by successive imaging studies Life expectancy less than 8 weeks Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival No prior myelodysplastic syndromes or leukemia PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: See Disease Characteristics At least 8 weeks Hematopoietic: Not specified Hepatic: No grade 3 or worse liver toxicity Renal: No grade 3 or worse renal toxicity Creatinine clearance at least 60 mL/min Cardiovascular: No grade 3 or worse cardiac toxicity Pulmonary: No grade 3 or worse pulmonary toxicity Other: Not pregnant No grade 3 or worse gastrointestinal toxicity No grade 3 or worse neurologic system toxicity No grade 4 hearing deficit No active life-threatening infection No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL No allergy to mouse proteins PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

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
Completado1 Centros de Estudio