A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors
temsirolimus
Enfermedades del Cerebro+8
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 2001
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in patients with advanced solid tumors (part I) who are not receiving anticonvulsant therapy. Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain metastases (part II) who are receiving anticonvulsant therapy. Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in these patients. OUTLINE: This is an open-label, dose-escalation study. Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day rest period. Treatment courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. The maximum tolerated dose for part I is defined as the dose level at which 33% of patients experience dose limiting toxicity. Part II: Patients receive the same treatment schedule as part I. Three patients with CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At least 3 patients are entered at each dose level in part II. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study within 8 months, and 12 patients will be accrued for part II within 7 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 15 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.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: Part I: Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I) Measurable or evaluable disease Part II: Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists Receiving anticonvulsants Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases) Renal: Creatinine less than 2 mg/dL Cardiovascular: No unstable angina No myocardial infarction within past 6 months No maintenance therapy for life-threatening arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection or other serious concurrent illness Triglycerides no greater than 300 mg/dL Cholesterol no greater than 350 mg/dL No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed No concurrent hormonal therapy Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agents At least 3 weeks since prior immunosuppressive therapy No concurrent anticonvulsant therapy (part I) No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide) No known agents that inhibit or induce cytochrome p450
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 2 ubicaciones
San Antonio Cancer Institute
San Antonio, United States