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

Completed · Phase 2

Conditions studied: Gastrointestinal Stromal Tumor, Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT00087074

Run by

National Cancer Institute (NCI)

People needed

55

Starts

2004-06-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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