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Trial record 1 of 1 for:    NCT00942747
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Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE July 20, 2009
First Posted Date  ICMJE July 21, 2009
Last Update Posted Date April 17, 2013
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
Overall response rate [ Time Frame: Weeks 4, 12, every 12 weeks thereafter ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
Official Title  ICMJE Phase 2 Study of Temsirolimus in Refractory and Recurrent Primary CNS Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Refractory Primary CNS Lymphoma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Temsirolimus
Weekly IV temsirolimus
Intervention: Drug: temsirolimus
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 20, 2009)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00942747
Other Study ID Numbers  ICMJE TemPCNSL
EudraCT 2009-011277-33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD Dr. Agnieszka Korfel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Agnieszka Korfel, MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP