Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
NCT ID: NCT00942747
Last Updated: 2013-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2009-07-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Temsirolimus
Weekly IV temsirolimus
temsirolimus
Weekly infusion of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months in the case of continuing response to treatment
Interventions
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temsirolimus
Weekly infusion of 25mg Temsirolimus (first 3 patients) or 75mg Temsirolimus (all other patients) up to a maximum of 12 months in the case of continuing response to treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Charite University, Berlin, Germany
OTHER
Responsible Party
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PD Dr. Agnieszka Korfel
PD Dr. Agnieszka Korfel
Principal Investigators
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Agnieszka Korfel, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité Campus Benjamin Franklin
Berlin, , Germany
Neurology, Knappschaftskrankenhaus Bochum, Bochum University
Bochum, , Germany
Neurology, University Hospital Bonn
Bonn, , Germany
Hematology, Klinikum Frankfurt/Oder
Frankfurt (Oder), , Germany
Hematology, University Hospital Heidelberg
Heidelberg, , Germany
Klinikum Grosshadern, University Hospital Munich
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Kuhn 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.
Smith 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).
Hess 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.
Ansell 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.
Witzig 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.
Costa 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.
Korfel A, Schlegel U, Herrlinger U, Dreyling M, Schmidt C, von Baumgarten L, Pezzutto A, Grobosch T, Kebir S, Thiel E, Martus P, Kiewe P. Phase II Trial of Temsirolimus for Relapsed/Refractory Primary CNS Lymphoma. J Clin Oncol. 2016 May 20;34(15):1757-63. doi: 10.1200/JCO.2015.64.9897. Epub 2016 Mar 14.
Other Identifiers
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EudraCT 2009-011277-33
Identifier Type: -
Identifier Source: secondary_id
TemPCNSL
Identifier Type: -
Identifier Source: org_study_id
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