Clinical trial · Interventional
CCI-779 in Treating Patients With Advanced Solid Tumors
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors
NCT00003712CI-TRIAL-00007795completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CCI-779 in treating patients who have advanced solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Part I: * Histologically proven advanced solid tumors that are refractory or for which no curative therapy exists * No CNS metastases, peritumoral edema, or symptomatic brain metastases (part I) * Measurable or evaluable disease Part II: * Histologically proven recurrent gliomas or brain metastases for which no curative therapy exists * Receiving anticonvulsants * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin less than 1.5 mg/dL * AST or ALT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if liver metastases) Renal: * Creatinine less than 2 mg/dL Cardiovascular: * No unstable angina * No myocardial infarction within past 6 months * No maintenance therapy for life-threatening arrhythmias Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No active infection or other serious concurrent illness * Triglycerides no greater than 300 mg/dL * Cholesterol no greater than 350 mg/dL * No known hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, or azithromycin) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) * No other concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids used to reduce edema in patients with primary or metastatic CNS tumors allowed * No concurrent hormonal therapy Radiotherapy: * At least 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * At least 1 month since prior investigational agents * At least 3 weeks since prior immunosuppressive therapy * No concurrent anticonvulsant therapy (part I) * No concurrent immunosuppressive therapy (e.g., terfenadine, cisapride, astemizole, pimozide) * No known agents that inhibit or induce cytochrome p450
References
Publications (0)
Data not yet available
No reference posted for this study.