To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?