Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme
Antineoplaston therapy (Atengenal + Astugenal)
Astrocitoma+5
+ Glioma
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 14 de marzo de 1995
Fecha en la que se inscribió al primer participante.OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme, as measured by an objective response to therapy (complete response, partial response or stable disease). To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 40 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 18 a 99 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: Histologically or cytologically confirmed Glioblastoma Multiforme Subtotal resection or biopsy only of tumor Measurable tumor by MRI scan performed within two weeks prior to study entry Tumor must be at least 5 mm No brain stem tumor PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 4 months Hematopoietic: WBC at least 1,500/mm^3 Platelet count at least 50,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: No hepatic failure Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that would contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunomodulatory agents Chemotherapy: No prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: Concurrent corticosteroids for cerebral edema allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery
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
Objetivos Secundarios
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