Clinical trial · Interventional
CCI-779 in Treating Patients With Malignant Glioma
Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma
NCT00022724CI-TRIAL-00033420completedPhase 1 / Phase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed intracranial malignant glioma * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Initial diagnosis of low-grade allowed, if subsequently progressed * Recurrent disease must have documented progression by MRI or CT scan * Progressive disease must have failed prior radiotherapy * Recent resection of recurrent or progressive tumor allowed provided all of the following are met: * Recovered from surgery * CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively * Concurrent steroid dosage must be stable * Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * WBC at least 3,000/mm3 * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 120,000/mm3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT less than 1.5 times ULN * Cholesterol less than 350 mg/dL * Triglycerides less than 400 mg/dL Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min Other: * No active infection * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant medical illness that would preclude study * No disease that would obscure toxicity or dangerously alter drug metabolism * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon Chemotherapy: * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 6 weeks since prior nitrosoureas * Phase I: * 2 prior chemotherapy regimens allowed * 1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR * 2 prior regimens for progressive tumor * Phase II: * No more than 1 prior chemotherapy regimen for recurrent malignant glioma * No prior chemotherapy allowed for stable glioblastoma multiforme Endocrine therapy: * See Disease Characteristics * At least 1 week since prior tamoxifen Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy for progressive disease * No more than 1 month since prior radiotherapy for nonprogressive glioblastoma multiforme Surgery: * See Disease Characteristics Other: * Recovered from prior therapy * At least 1 week since prior noncytotoxic agents
References
Publications (3)
- RESULTKuhn JG, Chang SM, Wen PY, Cloughesy TF, Greenberg H, Schiff D, Conrad C, Fink KL, Robins HI, Mehta M, DeAngelis L, Raizer J, Hess K, Lamborn KR, Dancey J, Prados MD; North American Brain Tumor Consortium and the National Cancer Institute. Pharmacokinetic and tumor distribution characteristics of temsirolimus in patients with recurrent malignant glioma. Clin Cancer Res. 2007 Dec 15;13(24):7401-6. doi: 10.1158/1078-0432.CCR-07-0781. PMID 18094423
- RESULTChang SM, Wen P, Cloughesy T, Greenberg H, Schiff D, Conrad C, Fink K, Robins HI, De Angelis L, Raizer J, Hess K, Aldape K, Lamborn KR, Kuhn J, Dancey J, Prados MD; North American Brain Tumor Consortium and the National Cancer Institute. Phase II study of CCI-779 in patients with recurrent glioblastoma multiforme. Invest New Drugs. 2005 Aug;23(4):357-61. doi: 10.1007/s10637-005-1444-0. PMID 16012795
- RESULTChang SM, Kuhn J, Wen P, Greenberg H, Schiff D, Conrad C, Fink K, Robins HI, Cloughesy T, De Angelis L, Razier J, Hess K, Dancey J, Prados MD; North American Brain Tumor Consortium And The National Cancer Institute. Phase I/pharmacokinetic study of CCI-779 in patients with recurrent malignant glioma on enzyme-inducing antiepileptic drugs. Invest New Drugs. 2004 Nov;22(4):427-35. doi: 10.1023/B:DRUG.0000036685.72140.03. PMID 15292713