Status:
UNKNOWN
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Pfizer
Conditions:
Recurrent or Refractory Primary CNS Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 regim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00942747
Start Date
July 1 2009
End Date
June 1 2014
Last Update
April 17 2013
Active Locations (6)
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1
Charité Campus Benjamin Franklin
Berlin, Germany, 12200
2
Neurology, Knappschaftskrankenhaus Bochum, Bochum University
Bochum, Germany, 44892
3
Neurology, University Hospital Bonn
Bonn, Germany, 53127
4
Hematology, Klinikum Frankfurt/Oder
Frankfurt (Oder), Germany, 15236