Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
Sargramostim
+ cyclophosphamide
+ melphalan
Enfermedades del Cerebro+10
+ Enfermedades del Sistema Nervioso Central
+ Glioma
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de septiembre de 1994
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell rescue. Determine the acute and delayed toxic effects of this regimen in these patients. OUTLINE: Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover. Patients are followed every 6 months through year 4 and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 31 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.De 2 a 25 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Diagnosis of recurrent medulloblastoma or CNS germ cell tumor Histologic review of the primary intracranial or spinal cord tumor required Biopsy and reduction of tumor bulk prior to study encouraged but not required No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy Patients with progression on salvage therapy ineligible Minimal residual disease (tumor bulk no more than 1.5 cm) or in second clinical complete remission (CR) Bone marrow infiltration with or without mass lesions or isolated abnormal CSF cytology as the only manifestation of recurrent disease allowed if a clinical CR is first achieved with conventional therapy PATIENT CHARACTERISTICS: Age: 2 to 25 Performance status: Karnofsky 80-100% Life expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 80 IU Renal: Creatinine less than 1.2 mg/dL Cardiovascular: LVEF normal Other: No infection Able to tolerate vigorous hydration Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior cyclophosphamide or ifosfamide allowed Endocrine therapy: No concurrent dexamethasone as an antiemetic Other concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics Pretransplantation radiotherapy boost allowed Surgery: See Disease Characteristics Pretransplantation surgery allowed Other: At least 4 weeks since prior therapy except corticosteroids
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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 118 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsUniversity of South Alabama Medical Center
Mobile, United StatesArizona Cancer Center
Tucson, United StatesUniversity of Arkansas for Medical Sciences
Little Rock, United States