A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.

Inclusion Criteria:

- Histologically or cytologic confirmed soft tissue sarcoma

- Measurable disease; for patients having only lesions measuring at least 1 cm to less
than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor
assessments

- Absolute neutrophil count (ANC) >= 1,500/μL

- Platelets (PLTS) >= 100,000/μL

- Hgb >= 10.0 g/dL

- Direct bilirubin =< 1.5 x ULN (upper limit normal)

- AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present

- ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present

- Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2

- Baseline glucose levels

- Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)

- Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)

- ECOG Performance Status (PS) 0, 1 or 2

- Life expectancy >= 12 weeks

- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent

Exclusion Criteria:

- Any of the following as this regimen may be harmful to a developing fetus or nursing
child:

- Pregnant women

- Breast-feeding women

- Men or women of childbearing potential or their sexual partners who are
unwilling to employ adequate contraception ( diaphragm, birth control pills,
injections, intrauterine device [IUD], surgical sterilization, subcutaneous
implants, or abstinence, etc.)

- Any of the following:

- Nitrosoureas or mitomycin =< 6 weeks prior to study entry

- Other chemotherapy =< 4 weeks prior to study entry

- Radiotherapy =< 4 weeks prior to study entry

- Concurrent use of any other investigation agent

- Adverse events due to agents administered =< 4 weeks prior to study entry

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to CCI-779

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Known HIV-positive patients receiving combination anti-retroviral therapy

- Prior chemotherapy for metastatic disease

- Exceptions:

- Patients with GIST who fail Gleevec are eligible

- Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible

- Known brain metastases

- Exception: Patients with treated brain metastatic disease with stable symptoms
after treatment for >= 1 month