Sirolimus in Treating Patients With Metastatic or Unresectable Solid Tumors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed solid tumor malignancy
• * Metastatic or inoperable disease
• * Failed curative or standard palliative therapy OR no such therapy exists
• Evaluable or measurable disease
• * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Tumor amenable to serial biopsies
• No known brain metastases
• PATIENT CHARACTERISTICS:
• ECOG 0-1
• Life expectancy ≥ 3 months
• WBC \> 3,500/mm³
• Absolute neutrophil count \> 1,500/mm³
• Hemoglobin \> 9 g/dL
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 2 mg/dL
• ALT and AST ≤ 5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times ULN
• Triglycerides \< 2 times ULN
• Total cholesterol \< 2 times ULN
• Willing to undergo serial tumor biopsies and normal skin biopsies
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No immunodeficiency
• No gastrointestinal tract disease resulting in an inability to take oral medication
• No requirement for IV alimentation
• No active peptic ulcer disease
• No active infections
• No other uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy
• No concurrent or second malignancy within the past 5 years
• No clinically significant cardiovascular disease, including any of the following:
• * Myocardial infarction within the past 12 months
• * Unstable angina
• * Peripheral vascular disease ≥ grade 2
• * Uncontrolled congestive heart failure
• * Uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 170 mm Hg, diastolic BP \> 95 mm Hg)
• PRIOR CONCURRENT THERAPY:
• Recovered from prior anticancer therapy
• * No unresolved chronic toxicity \> CTC grade 2
• No prior surgical procedures affecting absorption
• More than 4 weeks since prior surgery except minor procedures (e.g., dental work or skin biopsy)
• More than 1 month since prior participation in an investigational drug trial
• More than 1 month since prior chemotherapy
• No concurrent use of any of the following:
• * Phenytoin
• * Carbamazepine
• * Barbiturates
• * Rifampin
• * Phenobarbital
• * Cyclosporine
• * Clarithromycin
• * Diltiazen
• * Clotrimazole
• * Ketoconazole
• * Fluconazole
• * Hypericum perforatum (St. John's wort)
• * Cimetidine
• * Grapefruit juice
• No concurrent immunosuppressants
• No other concurrent investigational or commercial agents or therapies for this malignancy