CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

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