Recurrent or Refractory Primary CNS LymphomaPhase 2NCT00942747
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
A Phase 2 study testing temsirolimus in people with Recurrent or Refractory Primary CNS Lymphoma, run by Charite University, Berlin, Germany at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Refractory Primary CNS Lymphoma
- What is being tested?
- temsirolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 6 sitesGermany
- Study dates
- Jul 2009to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Charité Campus Benjamin Franklin
Berlin, 12200
Agnieszka Korfel, MD, +49308445 ext. 4096, agnieszka.korfel@charite.de
Philipp Kiewe, MD, +493064499 ext. 5225, philipp.kiewe@charite.de
- Recruiting
Neurology, Knappschaftskrankenhaus Bochum, Bochum University
Bochum, 44892
Uwe Schlegel, MD, +49-2342993701, simone.middelhauve@kk-bochum.de
Simone Middelhauve, +49-2342993701, simone.middelhauve@kk-bochum.de
- Recruiting
Neurology, University Hospital Bonn
Bonn, 53127
Ulrich Herrlinger, MD, +49-222828719887, christiane.landwehr@ukb.uni-bonn.de
Christiane Landwehr, +49-222828719887, christiane.landwehr@ukb.uni-bonn.de
- Not yet recruiting
Hematology, Klinikum Frankfurt/Oder
Frankfurt (Oder), 15236
Michael Kiel, MD, +4933-55484604, melanie.binsker@klinikum-ffo.de
Melanie Binsker, +4933-55484604, melanie.binsker@klinikum-ffo.de
- Not yet recruiting
Hematology, University Hospital Heidelberg
Heidelberg, 69120
Gerlinde Egerer, MD, +49-6221568029, martina.gronkowski@med.uni-heidelberg.de
Martina Gronkowski, +49-6221568029, martina.gronkowski@med.uni-heidelberg.de
- Recruiting
Klinikum Grosshadern, University Hospital Munich
Munich, 81377
Martin Dreyling, MD, +498970955202, carmen.carlucci@med.uni-muenchen.de
Carmen Carlucci, +498970955202, carmen.carlucci@med.uni-muenchen.de
About this study
Official title: Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma
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.
- Being tested
- temsirolimus
- Keywords
- temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temsirolimusDrug
Also called Torisel, CCI-770
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
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | Weekly IV temsirolimus Receives: Drug: temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Weeks 4, 12, every 12 weeks thereafter
Secondary outcomes (3)
Safety
Measured: continuous
Time to progression of disease
Measured: Weeks 4, 12, every 12 weeks thereafter or upon clinical suspicion of disease progression
Penetration of temsirolimus into cerebrospinal fluid
Measured: Weeks 1, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Recurrent or Refractory Primary CNS LymphomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
- Investigators
- Agnieszka Korfel, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942747
- Sponsor's protocol ID
- TemPCNSL
- Other IDs
- EudraCT 2009-011277-33
- Status last verified
- Apr 2013
- First submitted
- 20 Jul 2009
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18094423Smith 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.
PubMed 19581539Ansell 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.
PubMed 18543327Witzig 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.
PubMed 15983389Costa 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.
PubMed 17161912Korfel 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.
PubMed 26976424
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT00942747
- Acronym / sponsor ID
- TemPCNSL
- Keywords
- temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Drug: temsirolimusWeekly IV temsirolimus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temsirolimusAlso: Torisel, CCI-770Weekly 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 | Drug | Temsirolimus |
Primary outcome
Overall response rate
Time frame: Weeks 4, 12, every 12 weeks thereafter
3 secondary outcomes
Safety
Time frame: continuous
Time to progression of disease
Time frame: Weeks 4, 12, every 12 weeks thereafter or upon clinical suspicion of disease progression
Penetration of temsirolimus into cerebrospinal fluid
Time frame: Weeks 1, 4 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Background: PubMed 18094423Kuhn 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.
- 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).
- Background: PubMed 19581539Hess 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.
- Background: PubMed 18543327Ansell 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.
- Background: PubMed 15983389Witzig 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.
- Background: PubMed 17161912Costa 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.
- Derived from this study: PubMed 26976424Korfel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Korfel, MD principal investigator
Charite University, Berlin, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temsirolimus in people with Recurrent or Refractory Primary CNS Lymphoma, run by Charite University, Berlin, Germany at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Korfel, MD (+49308445 ext. 4096, agnieszka.korfel@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Weeks 4, 12, every 12 weeks thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00942747, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.