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Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942747
Recruitment Status : Unknown
Verified April 2013 by PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : July 21, 2009
Last Update Posted : April 17, 2013
Information provided by (Responsible Party):
PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Recurrent or Refractory Primary CNS Lymphoma Drug: temsirolimus Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma
Study Start Date : July 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Temsirolimus
Weekly IV temsirolimus
Drug: 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 Names:
  • Torisel
  • CCI-770

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Weeks 4, 12, every 12 weeks thereafter ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: continuous ]
  2. Time to progression of disease [ Time Frame: Weeks 4, 12, every 12 weeks thereafter or upon clinical suspicion of disease progression ]
  3. Penetration of temsirolimus into cerebrospinal fluid [ Time Frame: Weeks 1, 4 and 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00942747

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Contact: Agnieszka Korfel, MD +49308445 ext 4096
Contact: Philipp Kiewe, MD +493064499 ext 5225

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Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Agnieszka Korfel, MD    +49308445 ext 4096   
Contact: Philipp Kiewe, MD    +493064499 ext 5225   
Sub-Investigator: Philipp Kiewe, MD         
Principal Investigator: Agnieszka Korfel, MD         
Sub-Investigator: Martin Neumann, MD         
Sub-Investigator: Stephan Kreher, MD         
Neurology, Knappschaftskrankenhaus Bochum, Bochum University Recruiting
Bochum, Germany, 44892
Contact: Uwe Schlegel, MD    +49-2342993701   
Contact: Simone Middelhauve    +49-2342993701   
Neurology, University Hospital Bonn Recruiting
Bonn, Germany, 53127
Contact: Ulrich Herrlinger, MD    +49-222828719887   
Contact: Christiane Landwehr    +49-222828719887   
Hematology, Klinikum Frankfurt/Oder Not yet recruiting
Frankfurt an der Oder, Germany, 15236
Contact: Michael Kiel, MD    +4933-55484604   
Contact: Melanie Binsker    +4933-55484604   
Hematology, University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Contact: Gerlinde Egerer, MD    +49-6221568029   
Contact: Martina Gronkowski    +49-6221568029   
Klinikum Grosshadern, University Hospital Munich Recruiting
Munich, Germany, 81377
Contact: Martin Dreyling, MD    +498970955202   
Contact: Carmen Carlucci    +498970955202   
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Agnieszka Korfel, MD Charite University, Berlin, Germany

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).

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany Identifier: NCT00942747    
Other Study ID Numbers: TemPCNSL
EudraCT 2009-011277-33
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Keywords provided by PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany:
temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents