Phase II Study of Antineoplastons A10 and AS2-1 Capsules in Patients With Adenocarcinoma of the Colon
antineoplaston A10
+ antineoplaston AS2-1
+ alternative product therapy
Enfermedades del colon+8
+ Enfermedades del Sistema Digestivo
+ Neoplasias del sistema digestivo
Estudio de Tratamiento
Resumen
OBJECTIVES: Determine the antitumor activity of antineoplastons A10 and AS2-1 in patients with adenocarcinoma of the colon by determining the proportion of patients who experience an objective tumor response. Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of oral antineoplaston A10 and oral antineoplaston AS2-1 6-7 times a day. If the patient has not achieved a partial or complete response after 3-4 months of treatment, the investigator may discontinue treatment. Patients with stable disease may continue to receive treatment until disease progression or unacceptable toxicity is observed. Tumors are measured every 4 months during the first 2 years, then every 6 months during years 3 and 4, and yearly during years 5 and 6. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.A partir de 18 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 confirmed adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists Measurable disease by MRI or CT scan Metastatic or unresectable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal No hepatic failure Renal: Creatinine no greater than 2.5 mg/dL No renal failure Cardiovascular: No chronic heart failure No uncontrolled hypertension Pulmonary: No serious lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No active infection No serious malabsorption syndromes No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) Surgery: No prior extensive stomach or intestinal surgery Other: Prior cytodifferentiating agent allowed No prior antineoplaston therapy No other concurrent anticancer therapy
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