CCI-779 in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •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