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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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
Charité Campus Benjamin Franklin
Berlin, Germany
RECRUITINGNeurology, Knappschaftskrankenhaus Bochum, Bochum University
Bochum, Germany
RECRUITINGNeurology, University Hospital Bonn
Bonn, Germany
RECRUITINGHematology, Klinikum Frankfurt/Oder
Frankfurt (Oder), Germany
NOT_YET_RECRUITINGHematology, University Hospital Heidelberg
Heidelberg, Germany
NOT_YET_RECRUITINGKlinikum Grosshadern, University Hospital Munich
Munich, Germany
RECRUITINGOverall response rate
Time frame: Weeks 4, 12, every 12 weeks thereafter
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
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