Trial Title:
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
NCT ID:
NCT00942747
Condition:
Recurrent or Refractory Primary CNS Lymphoma
Conditions: Official terms:
Lymphoma
Recurrence
Sirolimus
Temsirolimus
MTOR Inhibitors
Conditions: Keywords:
temsirolimus, primary CNS lymphoma, PCNSL, salvage treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
temsirolimus
Description:
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
Arm group label:
Temsirolimus
Other name:
Torisel
Other name:
CCI-770
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Charité Campus Benjamin Franklin
Address:
City:
Berlin
Zip:
12200
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Agnieszka Korfel, MD
Phone:
+49308445
Phone ext:
4096
Email:
agnieszka.korfel@charite.de
Contact backup:
Last name:
Philipp Kiewe, MD
Phone:
+493064499
Phone ext:
5225
Email:
philipp.kiewe@charite.de
Investigator:
Last name:
Philipp Kiewe, MD
Email:
Sub-Investigator
Investigator:
Last name:
Agnieszka Korfel, MD
Email:
Principal Investigator
Investigator:
Last name:
Martin Neumann, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephan Kreher, MD
Email:
Sub-Investigator
Facility:
Name:
Neurology, Knappschaftskrankenhaus Bochum, Bochum University
Address:
City:
Bochum
Zip:
44892
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Uwe Schlegel, MD
Phone:
+49-2342993701
Email:
simone.middelhauve@kk-bochum.de
Contact backup:
Last name:
Simone Middelhauve
Phone:
+49-2342993701
Email:
simone.middelhauve@kk-bochum.de
Facility:
Name:
Neurology, University Hospital Bonn
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ulrich Herrlinger, MD
Phone:
+49-222828719887
Email:
christiane.landwehr@ukb.uni-bonn.de
Contact backup:
Last name:
Christiane Landwehr
Phone:
+49-222828719887
Email:
christiane.landwehr@ukb.uni-bonn.de
Facility:
Name:
Hematology, Klinikum Frankfurt/Oder
Address:
City:
Frankfurt an der Oder
Zip:
15236
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Michael Kiel, MD
Phone:
+4933-55484604
Email:
melanie.binsker@klinikum-ffo.de
Contact backup:
Last name:
Melanie Binsker
Phone:
+4933-55484604
Email:
melanie.binsker@klinikum-ffo.de
Facility:
Name:
Hematology, University Hospital Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Gerlinde Egerer, MD
Phone:
+49-6221568029
Email:
martina.gronkowski@med.uni-heidelberg.de
Contact backup:
Last name:
Martina Gronkowski
Phone:
+49-6221568029
Email:
martina.gronkowski@med.uni-heidelberg.de
Facility:
Name:
Klinikum Grosshadern, University Hospital Munich
Address:
City:
Munich
Zip:
81377
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Dreyling, MD
Phone:
+498970955202
Email:
carmen.carlucci@med.uni-muenchen.de
Contact backup:
Last name:
Carmen Carlucci
Phone:
+498970955202
Email:
carmen.carlucci@med.uni-muenchen.de
Start date:
July 2009
Completion date:
June 2014
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00942747
