Clinical trial · Interventional
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma
NCT00942747CI-TRIAL-00010076unknownPhase 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 is an open-label trial investigating the efficacy of temsirolimus in recurrent or refractory primary CNS lymphoma (PCNSL) after initial chemotherapy with a high-dose methotrexate containing regimen. 37 patients are planned to be treated with weekly infusions of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months. The trial is designed in two stages, if less than one of the first 12 patients responds to treatment, the trial is stopped. In addition to efficacy, safety and penetration of temsirolimus into the cerebrospinal fluid will be investigated.
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 |
|---|---|---|---|
| Recurrent or Refractory Primary CNS Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temsirolimus
- description
- Weekly IV temsirolimus
- interventionNames
- Drug: temsirolimus
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Weeks 4, 12, every 12 weeks thereafter
Secondary outcomes (3)
- measure
- Safety
- timeFrame
- continuous
- measure
- Time to progression of disease
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestations * Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate * ECOG performance score ≤ 2 * Age ≥18 years and ≤ 75 years * Life expectancy of at least 3 months * Absence of active infection * Negative HIV serology * Adequate renal function (GFR \>30ml/h) * Adequate bone marrow reserve (neutrophils \> 1500/µl, platelets \> 80,000/µl) * Bilirubin \<1.5x upper limit of normal (ULN), ALT and AST \<3x ULN * At least 3 weeks interval from prior cytostatic treatment * Negative pregnancy test * Patient accessible for treatment and follow-up * Patient compliance * Signed informed consent Exclusion Criteria: * Secondary CNS lymphoma * Primary intraocular lymphoma * Patient eligible for high-dose chemotherapy and autologous stem-cell transplantation * Concurrent treatment within another clinical trial * Concurrent other malignant disease * Symptomatic congestive heart failure (≥NYHA II) * Active or uncontrolled chronic infection * Severe concomitant disease incompatible with study conduct * History of cerebral bleeding * Concomitant treatment with strong CYP3A4/5-inductors or -inhibitors * Premenopausal women without highly effective contraception (defined as Pearl index \<1) * Pregnant or lactating women * Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol * Concurrent admission to a psychiatric institution by public order
References
Publications (7)
- BACKGROUNDKuhn 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
- BACKGROUNDSmith SM, Pro B, Cisneros A, Smith S, Stiff P, Lester E, Modi S, Dancey JE, Vokes EE, van Besien E. Activity of single agent temsirolimus (CCI-779) in non-mantle cell non-Hodgkin lymphoma subtypes. J Clin Oncol 2008:26 (May 20 suppl; abstr 8514).
- BACKGROUNDHess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, Laurell A, Offner F, Strahs A, Berkenblit A, Hanushevsky O, Clancy J, Hewes B, Moore L, Coiffier B. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009 Aug 10;27(23):3822-9. doi: 10.1200/JCO.2008.20.7977. Epub 2009 Jul 6. PMID 19581539
- BACKGROUNDAnsell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. doi: 10.1002/cncr.23580. PMID 18543327
- BACKGROUNDWitzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. doi: 10.1200/JCO.2005.13.466. Epub 2005 Jun 27. PMID 15983389
- BACKGROUNDCosta LJ. Aspects of mTOR biology and the use of mTOR inhibitors in non-Hodgkin's lymphoma. Cancer Treat Rev. 2007 Feb;33(1):78-84. doi: 10.1016/j.ctrv.2006.10.004. Epub 2006 Dec 11.