A therapy and pharmacokinetics study of temsirolimus in patients with refractory and recidivated primary CNS lymphoma - Temsirolimus in PZNS

• Conditions: Patients with refractory and recidivated primary CNS lymphoma

• Registration Number: EUCTR2009-011277-33-DE
• Lead Sponsor: Charité - University Hospital of Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions
- 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 and = 75 years
- Life expectancy of at least 3 months
- Absence of active infection
- Negative HIV serology
- Adequate renal function (GFR >30ml/min)
- Adequate bone marrow resere (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 written informed consent (AMG §40 (1) 3b)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
- Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions
- 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 and = 75 years
- Life expectancy of at least 3 months
- Absence of active infection
- Negative HIV serology
- Adequate renal function (GFR >30ml/min)
- Adequate bone marrow resere (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 written informed consent (AMG §40 (1) 3b)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Secundary CNS lymphoma
- Primary intraocular lymphoma
- Concurrent treatment within another clinical trial
- Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation
- 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
- Subjects who are legally detained in an official institute
;
- Secundary CNS lymphoma
- Primary intraocular lymphoma
- Concurrent treatment within another clinical trial
- Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation
- 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
- Subjects who are legally detained in an official institute

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to assess efficacy of Temsirolimus in patients with refractory and recidivated primary CNS lymphoma;Secondary Objective: ;Primary end point(s): Overall response rate (partial or complete remission) ;Main Objective: The objective of this study is to assess efficacy of Temsirolimus in patients with refractory and recidivated primary CNS lymphoma;Secondary Objective: ;Primary end point(s): Overall response rate (partial or complete remission)