Clinical trial · Interventional
CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.
NCT00087074CI-TRIAL-00010532completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage I Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage II Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IV Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (temsirolimus)
- description
- 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.
- interventionNames
- Drug: temsirolimus
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
- timeFrame
- Up to 6 months (6 courses)
Secondary outcomes (4)
- measure
- Survival time
- timeFrame
- Time from registration to death due to any cause, assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 monthReferences
Publications (0)
Data not yet available
No reference posted for this study.