Status:
COMPLETED
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Stromal Tumor
Recurrent Adult Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00087074
Start Date
June 1 2004
Last Update
June 4 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905