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Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

This study is currently recruiting participants.
Verified April 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00942747
First received: July 20, 2009
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Recurrent or Refractory Primary CNS Lymphoma
 Drug: temsirolimus
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Weeks 4, 12, every 12 weeks thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Time to progression of disease [ Time Frame: Weeks 4, 12, every 12 weeks thereafter or upon clinical suspicion of disease progression ] [ Designated as safety issue: No ]
  • Penetration of temsirolimus into cerebrospinal fluid [ Time Frame: Weeks 1, 4 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942747

Contacts
Contact: Agnieszka Korfel, MD +49308445 ext 4096 agnieszka.korfel@charite.de
Contact: Philipp Kiewe, MD +493064499 ext 5225 philipp.kiewe@charite.de

Locations
Germany
Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Agnieszka Korfel, MD     +49308445 ext 4096     agnieszka.korfel@charite.de    
Contact: Philipp Kiewe, MD     +493064499 ext 5225     philipp.kiewe@charite.de    
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     simone.middelhauve@kk-bochum.de    
Contact: Simone Middelhauve     +49-2342993701     simone.middelhauve@kk-bochum.de    
Neurology, University Hospital Bonn Recruiting
Bonn, Germany, 53127
Contact: Ulrich Herrlinger, MD     +49-222828719887     christiane.landwehr@ukb.uni-bonn.de    
Contact: Christiane Landwehr     +49-222828719887     christiane.landwehr@ukb.uni-bonn.de    
Hematology, Klinikum Frankfurt/Oder Not yet recruiting
Frankfurt an der Oder, Germany, 15236
Contact: Michael Kiel, MD     +4933-55484604     melanie.binsker@klinikum-ffo.de    
Contact: Melanie Binsker     +4933-55484604     melanie.binsker@klinikum-ffo.de    
Hematology, University Hospital Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Contact: Gerlinde Egerer, MD     +49-6221568029     martina.gronkowski@med.uni-heidelberg.de    
Contact: Martina Gronkowski     +49-6221568029     martina.gronkowski@med.uni-heidelberg.de    
Klinikum Grosshadern, University Hospital Munich Recruiting
Munich, Germany, 81377
Contact: Martin Dreyling, MD     +498970955202     carmen.carlucci@med.uni-muenchen.de    
Contact: Carmen Carlucci     +498970955202     carmen.carlucci@med.uni-muenchen.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Pfizer
Investigators
Principal Investigator: Agnieszka Korfel, MD Charite University, Berlin, Germany
  More Information

Publications:
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).

Responsible Party: PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00942747     History of Changes
Other Study ID Numbers: TemPCNSL, EudraCT 2009-011277-33
Study First Received: July 20, 2009
Last Updated: April 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 21, 2013