Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: I. To assess the antitumor activity of CCI-779 in this patient population. SECONDARY OBJECTIVES: I. To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779: duration of response, time to progression, survival. TERTIARY OBJECTIVES: I. To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779: relative levels of 4EBP1 to eIF4E, phospho 4EBP1, total and phospho ribosomal S6 on pretreatment tumor tissue, expression levels of EGFR, activated EGFR, Her2, c-Myc, phospho Akt, total Akt, phospho-mTOR and total mTOR on pretreatment tumor tissue, drug induced inhibition of p70S6 kinase activity, and phosphorylation of S6 in PBMC, relative levels of serum sirolimus in post-treatment samples. OUTLINE: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.


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


NCT ID:

NCT00087074


Primary Contact:

Principal Investigator
Scott Okuno
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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